We are seeking an experienced Principal Statistician to join our growing team. The successful applicant will work as part of global teams, supporting pharmaceutical, biotechnology and medical device companies across many therapeutic areas. Quanticate values quality first, integrity, care, people, commitment to delivery, and inspiration. As such, employees are offered flexible and friendly working conditions, competitive pay, industry-leading benefits, and opportunities for progression, in an environment where they are mixing with the very best experts in the field. As Principal Statistician, you will be responsible for the development, validation, and implementation of statistical models and providing statistical support for clinical studies. You will serve as a Statistical Lead for large-scale clinical trials across various therapeutic areas, ensuring that all deliverables are achieved on time and to a high level of quality.Youwill lead Statistical Consultancy Projects, advising clients on all aspects of statistical trial design and conduct. Key to the role is, the ability to provide face to face advice to clients on all elements of study design, whether frequentist or Bayesian in nature. Having experience of using simulation methods in trial design would be an advantage but not essential. Through all activities you will also provide guidance and mentorship to other statisticians in the group. Responsibilities Serve as lead statistician for clinical trials including planning, analysing, and reporting, ensuring that all deliverables are met on time and to a high level of quality. Develop and validate statistical models and analyses based on study protocols. Write statistical analysis plans and reports. Provide guidance and mentorship to other statisticians in the group. Collaborate with cross-functional teams to develop study protocols and ensure they meet regulatory requirements. To potentially take line management responsibility for junior statisticians within the team. To lead statistical consultancy projects as required, providing expert statistical advice on all statistical aspects of study design and conduct. Perform ad hoc statistical duties as required MSc in Biostatistics, Medical Statistics or equivalent. Strong statistical expertise with experience in clinical trials. Experience in SAS programming. Extensive knowledge of regulatory requirements for clinical trials. Strong project management and leadership skills with experience leading large-scale projects. Excellent verbal and written communication skills. Ability to work independently and as part of a team. Willingness to travel when needed. Competitive Salary (Open to discussion based on experience) Home working allowance Flexible working hours 25 days Annual leave plus bank holidays Option to purchase additional days holiday Pension with Company matching Private medical Scheme with Bupa Free standard eye test every two years Employee Assistance Program - Available for employee and immediate family 5, 10, 15 years of service recognition awards Death in service scheme Long Term Disability Insurance Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)
Aug 13, 2025
Full time
We are seeking an experienced Principal Statistician to join our growing team. The successful applicant will work as part of global teams, supporting pharmaceutical, biotechnology and medical device companies across many therapeutic areas. Quanticate values quality first, integrity, care, people, commitment to delivery, and inspiration. As such, employees are offered flexible and friendly working conditions, competitive pay, industry-leading benefits, and opportunities for progression, in an environment where they are mixing with the very best experts in the field. As Principal Statistician, you will be responsible for the development, validation, and implementation of statistical models and providing statistical support for clinical studies. You will serve as a Statistical Lead for large-scale clinical trials across various therapeutic areas, ensuring that all deliverables are achieved on time and to a high level of quality.Youwill lead Statistical Consultancy Projects, advising clients on all aspects of statistical trial design and conduct. Key to the role is, the ability to provide face to face advice to clients on all elements of study design, whether frequentist or Bayesian in nature. Having experience of using simulation methods in trial design would be an advantage but not essential. Through all activities you will also provide guidance and mentorship to other statisticians in the group. Responsibilities Serve as lead statistician for clinical trials including planning, analysing, and reporting, ensuring that all deliverables are met on time and to a high level of quality. Develop and validate statistical models and analyses based on study protocols. Write statistical analysis plans and reports. Provide guidance and mentorship to other statisticians in the group. Collaborate with cross-functional teams to develop study protocols and ensure they meet regulatory requirements. To potentially take line management responsibility for junior statisticians within the team. To lead statistical consultancy projects as required, providing expert statistical advice on all statistical aspects of study design and conduct. Perform ad hoc statistical duties as required MSc in Biostatistics, Medical Statistics or equivalent. Strong statistical expertise with experience in clinical trials. Experience in SAS programming. Extensive knowledge of regulatory requirements for clinical trials. Strong project management and leadership skills with experience leading large-scale projects. Excellent verbal and written communication skills. Ability to work independently and as part of a team. Willingness to travel when needed. Competitive Salary (Open to discussion based on experience) Home working allowance Flexible working hours 25 days Annual leave plus bank holidays Option to purchase additional days holiday Pension with Company matching Private medical Scheme with Bupa Free standard eye test every two years Employee Assistance Program - Available for employee and immediate family 5, 10, 15 years of service recognition awards Death in service scheme Long Term Disability Insurance Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)
Location : Hybrid - ICNARC offices in central London and home Salary : Principal Statistician: £55£62k (depending on experience) Contract : Permanent Hours : Full time 37.5 hours per week Start : As soon as possible Closing date: When filled The Intensive Care National Audit & Research Centre (ICNARC) is an independent, not-for-profit, scientific organisation click apply for full job details
Aug 13, 2025
Full time
Location : Hybrid - ICNARC offices in central London and home Salary : Principal Statistician: £55£62k (depending on experience) Contract : Permanent Hours : Full time 37.5 hours per week Start : As soon as possible Closing date: When filled The Intensive Care National Audit & Research Centre (ICNARC) is an independent, not-for-profit, scientific organisation click apply for full job details
Principal Statistical Programmer page is loaded Principal Statistical Programmer Apply locations London (The Westworks) time type Full time posted on Posted 4 Days Ago job requisition id REQ- Job Description Summary -Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines. Job Description Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high-quality deliverables in Novartis Global Drug Development. Key Accountabilities: Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. Provide and implement statistical programming solutions; ensure knowledge sharing. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Your experience: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables. Plus R. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? : Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis Similar Jobs (2) Senior Principal Statistical Programmer locations London (The Westworks) time type Full time posted on Posted 3 Days Ago Senior Principal Statistical Programmer locations London (The Westworks) time type Full time posted on Posted 4 Days Ago Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives. Job Requisitions for China In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .
Aug 13, 2025
Full time
Principal Statistical Programmer page is loaded Principal Statistical Programmer Apply locations London (The Westworks) time type Full time posted on Posted 4 Days Ago job requisition id REQ- Job Description Summary -Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines. Job Description Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high-quality deliverables in Novartis Global Drug Development. Key Accountabilities: Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. Provide and implement statistical programming solutions; ensure knowledge sharing. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Your experience: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables. Plus R. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? : Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis Similar Jobs (2) Senior Principal Statistical Programmer locations London (The Westworks) time type Full time posted on Posted 3 Days Ago Senior Principal Statistical Programmer locations London (The Westworks) time type Full time posted on Posted 4 Days Ago Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives. Job Requisitions for China In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .
Newcastle University
Newcastle Upon Tyne, Tyne And Wear
Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you. Closing Date: 25 February 2025 The Role The purpose of this role is to understand how we can support older people to stay in their own home as they age. You will do this by modelling health data from longitudinal studies of health. This project is part of the Advanced Care Research Centre (ACRC) which is based at Edinburgh University. Newcastle University has an academic partnership to 'Understand the Person in Context'. Specifically, this role aims to investigate how to age in place successfully by understanding what it is and what shapes it. You will join us at the Population Health Sciences Institute and work with Professor Dame Louise Robinson, Professor Katie Brittain, Dr Kate Gibson and Dr Andrew Kingston. We are looking for a dynamic individual with a robust background in statistics evidenced by a strong publication record and a proven track record of analysing data both cross-sectionally and longitudinally (evidenced by publications). As a member of the team, you will analyse large complex datasets using advanced quantitative methods to answer policy and clinically relevant questions. You will be experienced in biostatistics/epidemiology and will be able to apply longitudinal/panel data methodology. Ideally you will be experienced in the manipulation and management of such datasets, and in the application of advanced methods. In addition, you will have experience of writing for a range of audiences to promote knowledge exchange and some understanding of and commitment to health research. This post is full time tenable until 31/12/2025. Key Accountabilities Although working under the general guidance of an academic or Principal Investigator, the postholder will contribute ideas, including enhancements to the technical or methodological aspects of their studies, thus providing substantial 'added value' Provide statistical expertise and support to investigators in the design, conduct and analysis of research projects and clinical trials Undertake analysis of research data and provide interpretation of results from ongoing projects under the supervision of a more experienced colleague Prepare reports for trial management group and oversight committees Draft and develop statistical analysis plans Comply with relevant regulatory requirements Undertake appropriate continuing professional development in order to develop and maintain competence in the best available statistical methods Disseminate research findings by writing up findings for publication Contribute to the teaching of biostatistics within the Institute/Faculty as appropriate Develop an awareness of University structures, policies and procedures and relevant issues in the higher education, research, social and political environment The Person Knowledge, Skills and Experience An up to date knowledge of current statistical techniques Experience in Biostatistics/epidemiology Experience in manipulation and management of large datasets Knowledge of one or more statistical analysis packages (STATA, SPSS, SAS, R) Ability to work flexibly and cooperatively with others, but also to work independently Demonstrable ability to work effectively Experience of working as part of a team Ability to write on statistical matters for publication in peer-reviewed journals Experience of providing statistical support for academics and other researchers Experience of applying statistics in a research setting Attributes and Behaviour Enthusiastic, innovative approach to challenges Ability to work to deadlines Ability to organise own workload, with minimum supervision and work effectively as part of a team Demonstrated commitment to ongoing personal development and training Qualifications MSc with substantial Medical Statistics content Newcastle University is a global University where everyone is treated with dignity and respect. We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams. At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality. We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education. We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme. In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Feb 17, 2025
Full time
Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you. Closing Date: 25 February 2025 The Role The purpose of this role is to understand how we can support older people to stay in their own home as they age. You will do this by modelling health data from longitudinal studies of health. This project is part of the Advanced Care Research Centre (ACRC) which is based at Edinburgh University. Newcastle University has an academic partnership to 'Understand the Person in Context'. Specifically, this role aims to investigate how to age in place successfully by understanding what it is and what shapes it. You will join us at the Population Health Sciences Institute and work with Professor Dame Louise Robinson, Professor Katie Brittain, Dr Kate Gibson and Dr Andrew Kingston. We are looking for a dynamic individual with a robust background in statistics evidenced by a strong publication record and a proven track record of analysing data both cross-sectionally and longitudinally (evidenced by publications). As a member of the team, you will analyse large complex datasets using advanced quantitative methods to answer policy and clinically relevant questions. You will be experienced in biostatistics/epidemiology and will be able to apply longitudinal/panel data methodology. Ideally you will be experienced in the manipulation and management of such datasets, and in the application of advanced methods. In addition, you will have experience of writing for a range of audiences to promote knowledge exchange and some understanding of and commitment to health research. This post is full time tenable until 31/12/2025. Key Accountabilities Although working under the general guidance of an academic or Principal Investigator, the postholder will contribute ideas, including enhancements to the technical or methodological aspects of their studies, thus providing substantial 'added value' Provide statistical expertise and support to investigators in the design, conduct and analysis of research projects and clinical trials Undertake analysis of research data and provide interpretation of results from ongoing projects under the supervision of a more experienced colleague Prepare reports for trial management group and oversight committees Draft and develop statistical analysis plans Comply with relevant regulatory requirements Undertake appropriate continuing professional development in order to develop and maintain competence in the best available statistical methods Disseminate research findings by writing up findings for publication Contribute to the teaching of biostatistics within the Institute/Faculty as appropriate Develop an awareness of University structures, policies and procedures and relevant issues in the higher education, research, social and political environment The Person Knowledge, Skills and Experience An up to date knowledge of current statistical techniques Experience in Biostatistics/epidemiology Experience in manipulation and management of large datasets Knowledge of one or more statistical analysis packages (STATA, SPSS, SAS, R) Ability to work flexibly and cooperatively with others, but also to work independently Demonstrable ability to work effectively Experience of working as part of a team Ability to write on statistical matters for publication in peer-reviewed journals Experience of providing statistical support for academics and other researchers Experience of applying statistics in a research setting Attributes and Behaviour Enthusiastic, innovative approach to challenges Ability to work to deadlines Ability to organise own workload, with minimum supervision and work effectively as part of a team Demonstrated commitment to ongoing personal development and training Qualifications MSc with substantial Medical Statistics content Newcastle University is a global University where everyone is treated with dignity and respect. We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams. At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality. We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education. We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme. In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: If you have the following characteristics, it would be a plus: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Excellent interpersonal and communication skills. Capability in building and maintaining strong working relationships in a team setting. Strong influencing skills applied effectively across functions and levels of an organization. Experience of working with and coordinating the work of CROs. Track record of strong statistical contributions and accomplishments in late phase clinical drug development. Self-motivated and independent worker. The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Feb 15, 2025
Full time
Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: If you have the following characteristics, it would be a plus: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Excellent interpersonal and communication skills. Capability in building and maintaining strong working relationships in a team setting. Strong influencing skills applied effectively across functions and levels of an organization. Experience of working with and coordinating the work of CROs. Track record of strong statistical contributions and accomplishments in late phase clinical drug development. Self-motivated and independent worker. The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
You will need to login before you can apply for a job. Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Self-motivated and independent worker. Compensation and Benefits: The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Feb 13, 2025
Full time
You will need to login before you can apply for a job. Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Self-motivated and independent worker. Compensation and Benefits: The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Senior Principal Statisticians / Biostatistics Senior Program Manager Location UK Remote/On-site or Hybrid Salary - £70-80k plus excellent benefits Do you enjoy working with world-class scientific and technical biometrics experts to help make a difference in the lives of patients worldwide? If you are a Snr / Principal Biostatistician looking for a senior opportunity to work in a position where you click apply for full job details
Dec 17, 2022
Full time
Senior Principal Statisticians / Biostatistics Senior Program Manager Location UK Remote/On-site or Hybrid Salary - £70-80k plus excellent benefits Do you enjoy working with world-class scientific and technical biometrics experts to help make a difference in the lives of patients worldwide? If you are a Snr / Principal Biostatistician looking for a senior opportunity to work in a position where you click apply for full job details
Locations: UK - Hertfordshire - Ware , UK - Hertfordshire - Stevenage USA - Pennsylvania - Upper Providence, Background info: Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the development of new medicines? We have an exciting opportunity for an applied s click apply for full job details
Nov 24, 2022
Full time
Locations: UK - Hertfordshire - Ware , UK - Hertfordshire - Stevenage USA - Pennsylvania - Upper Providence, Background info: Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the development of new medicines? We have an exciting opportunity for an applied s click apply for full job details
Clinical Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team who put quantitative rocket boosters under every project we touch and transform the pace, scale and success with which our company serves the patients who rely on us. We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical meth click apply for full job details
Nov 24, 2022
Full time
Clinical Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team who put quantitative rocket boosters under every project we touch and transform the pace, scale and success with which our company serves the patients who rely on us. We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical meth click apply for full job details
Clinical Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team who put quantitative rocket boosters under every project we touch and transform the pace, scale and success with which our company serves the patients who rely on us. We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical meth click apply for full job details
Nov 24, 2022
Full time
Clinical Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team who put quantitative rocket boosters under every project we touch and transform the pace, scale and success with which our company serves the patients who rely on us. We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical meth click apply for full job details
US Hiring Locations: Upper Providence, PA UK Hiring Locations: Stevenage, Hertfordshire Remote Working: Possible option Our team collaborates with top laboratory and clinical scientists to advance innovative ideas in drug discovery. We design experiments, analyze data, and visualize results for projects that range from small studies with single endpoints to high-dimensional genomic data click apply for full job details
Nov 24, 2022
Full time
US Hiring Locations: Upper Providence, PA UK Hiring Locations: Stevenage, Hertfordshire Remote Working: Possible option Our team collaborates with top laboratory and clinical scientists to advance innovative ideas in drug discovery. We design experiments, analyze data, and visualize results for projects that range from small studies with single endpoints to high-dimensional genomic data click apply for full job details
Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, Canada - Quebec - Laval, Home Worker - GBR, Home Worker - NLD, Netherlands - Amsterdam, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Jun Once GSK were a traditional SAS programming group, today, we're a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. Beyond this, we're investing in a new modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages. We have career opportunities across a range of experience levels from junior programmers to industry experienced programmers and leaders to support multiple business areas. Join us to help people do more, feel better, live longer. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines, therapies and vaccines is increasingly decided by scientific data and the effectiveness with which it can be captured, interrogated and understood. It's our job in Statistical Programming to equip our scientific experts with data that is seamlessly curated, analysed and visualised. We support every stage of the path that each potential drug progresses along, from non-clinical research to commercial launch and lifecycle management. How do we do it? We are transforming and becoming a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. We are investing in a new statistical computing environment, a multimillion-pound modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages (R, Python, SAS). Built-in automations will eliminate heavy manual and repetitive tasks and reduce cycle times from weeks to days. Additional initiatives include exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualisation capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. What can we offer you? The data we deal with is increasingly complex and diverse, demanding a pioneering programming and analytics environment and a workforce who are continuously expanding their technical skills and looking for ways to innovate and experiment. Beyond the satisfaction of varied and interesting work in support of a really worthwhile mission, we will grow and develop you as an individual contributor and a potential leader in the field. And we don't just invest in your technical competencies and capabilities. Communication, influencing and management skills as well as the ability to work in an agile and collaborative way are also important attributes of outstanding programmers and data specialists. Great results and high performers are rewarded, but also we're a team with real camaraderie who care about each other and enjoy working together. Would you like a progressive career at the leading edge of transformation and innovation? Come and join our diverse global team of programmers and data scientists as we unlock the power of automation, analytics and visualisations to accelerate delivery of medicines and vaccines. Patients around the world are counting on us." GSK is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Oncology Programming is committed to develop novel Oncology therapies; support Data Strategy and Disease Area Strategy; and contribute to Medical and Market Access efforts. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. HIV Clinical Programming excels at delivery in supporting ViiV Healthcare's mission to end the HIV epidemic and make sure no one living with HIV and AIDS is left behind. Innovative and scientifically curious, we pride ourselves on our collaboration with Clinical Statistics and wider team stakeholders . This is an exciting time to join this dynamic and cohesive team, working with a range of exciting programming platforms, to provide an emerging range of effective treatment options for our patients. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations: Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Principal Programmer/Lead - To lead and act as SME in your area Provide technical contribution to complex tasks Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Act as a subject matter expert within own discipline Initiate new directions and novel strategies to achieve department goals Project manage or lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Contribute to and influence the strategic planning and direction of a project Project manage and lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Programmer - to work within a team towards projects and to develop your own career Automation of data creation, graphs, tables and certain statistical analyses using R scripts Effectively explains technical concepts to non-technical colleagues Apply learning from previous activities to result in quicker and more efficient completion of the current task Share learnings with peers and contributes to internal technical discussions/forums Active member of external professional/ industry organization Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes Contributes to and influences the strategic planning and direction of a project Demonstrated knowledge of and experience in the application of CDISC data and standards When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience in R, SAS programming, and script/macro code development Working knowledge of relevant therapeutic area or industry to GSK projects such as oncology or clinical trials Preferred Qualifications (varies on level applied for) If you have the following characteristics, it would be a plus: MSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience with programming language(s) Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Experience with products such as R-Shiny, Python, JMP, SAS/GRAPH, SAS Output Delivery System Knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable) Takes responsibility for oversight of others work as assigned by manager Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Able to explain technical approaches to peers and non-technical colleagues/settings..... click apply for full job details
Sep 23, 2022
Full time
Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, Canada - Quebec - Laval, Home Worker - GBR, Home Worker - NLD, Netherlands - Amsterdam, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Jun Once GSK were a traditional SAS programming group, today, we're a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. Beyond this, we're investing in a new modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages. We have career opportunities across a range of experience levels from junior programmers to industry experienced programmers and leaders to support multiple business areas. Join us to help people do more, feel better, live longer. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines, therapies and vaccines is increasingly decided by scientific data and the effectiveness with which it can be captured, interrogated and understood. It's our job in Statistical Programming to equip our scientific experts with data that is seamlessly curated, analysed and visualised. We support every stage of the path that each potential drug progresses along, from non-clinical research to commercial launch and lifecycle management. How do we do it? We are transforming and becoming a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. We are investing in a new statistical computing environment, a multimillion-pound modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages (R, Python, SAS). Built-in automations will eliminate heavy manual and repetitive tasks and reduce cycle times from weeks to days. Additional initiatives include exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualisation capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. What can we offer you? The data we deal with is increasingly complex and diverse, demanding a pioneering programming and analytics environment and a workforce who are continuously expanding their technical skills and looking for ways to innovate and experiment. Beyond the satisfaction of varied and interesting work in support of a really worthwhile mission, we will grow and develop you as an individual contributor and a potential leader in the field. And we don't just invest in your technical competencies and capabilities. Communication, influencing and management skills as well as the ability to work in an agile and collaborative way are also important attributes of outstanding programmers and data specialists. Great results and high performers are rewarded, but also we're a team with real camaraderie who care about each other and enjoy working together. Would you like a progressive career at the leading edge of transformation and innovation? Come and join our diverse global team of programmers and data scientists as we unlock the power of automation, analytics and visualisations to accelerate delivery of medicines and vaccines. Patients around the world are counting on us." GSK is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Oncology Programming is committed to develop novel Oncology therapies; support Data Strategy and Disease Area Strategy; and contribute to Medical and Market Access efforts. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. HIV Clinical Programming excels at delivery in supporting ViiV Healthcare's mission to end the HIV epidemic and make sure no one living with HIV and AIDS is left behind. Innovative and scientifically curious, we pride ourselves on our collaboration with Clinical Statistics and wider team stakeholders . This is an exciting time to join this dynamic and cohesive team, working with a range of exciting programming platforms, to provide an emerging range of effective treatment options for our patients. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations: Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Principal Programmer/Lead - To lead and act as SME in your area Provide technical contribution to complex tasks Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Act as a subject matter expert within own discipline Initiate new directions and novel strategies to achieve department goals Project manage or lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Contribute to and influence the strategic planning and direction of a project Project manage and lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Programmer - to work within a team towards projects and to develop your own career Automation of data creation, graphs, tables and certain statistical analyses using R scripts Effectively explains technical concepts to non-technical colleagues Apply learning from previous activities to result in quicker and more efficient completion of the current task Share learnings with peers and contributes to internal technical discussions/forums Active member of external professional/ industry organization Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes Contributes to and influences the strategic planning and direction of a project Demonstrated knowledge of and experience in the application of CDISC data and standards When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience in R, SAS programming, and script/macro code development Working knowledge of relevant therapeutic area or industry to GSK projects such as oncology or clinical trials Preferred Qualifications (varies on level applied for) If you have the following characteristics, it would be a plus: MSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience with programming language(s) Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Experience with products such as R-Shiny, Python, JMP, SAS/GRAPH, SAS Output Delivery System Knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable) Takes responsibility for oversight of others work as assigned by manager Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Able to explain technical approaches to peers and non-technical colleagues/settings..... click apply for full job details
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
Sep 23, 2022
Full time
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
Site Name: UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Aug Our team collaborates with top laboratory and clinical scientists to advance exciting, innovative ideas in drug discovery. We design experiments, analyze data, and visualize results for projects that range from small studies with single endpoints to high-dimensional genomic data.We use traditional statistical methods and modern machine learning algorithms, design experiments to develop new technologies and analyze data to identify biomarkers for clinical trials. Our work is varied and challenging with the common goal to advance the science of human health. To succeed, team members need good technical and communication skills, the desire to develop their statistical and scientific knowledge continually, and the ability to develop practical solutions and apply statistical techniques in creative ways. Successful candidates will be innovative, pragmatic, and flexible, thriving in a dynamic, collegial environment with frequent new challenges and excellent opportunities to develop and succeed. In this role, you will be responsible for providing statistical consulting for 1-2 scientific research areas within GSK. Key Responsibilities include, but are not limited to (Varies on position level): Collaborating closely with GSK scientists and scientific management to address important drug discovery questions with statistical methods Identifying key scientific challenges that can be addressed with statistical methods and proposing how to do so Applying existing statistical methods or developing new ones to address scientific problems Designing experiments and ensuring experiments are designed to address scientific questions clearly and accurately Analyzing data and ensuring the results of statistical analyses can be relied upon for making important drug discovery decisions around targets, molecules, and technologies Communicating statistical concepts, design recommendations, and the results of statistical analyses clearly and accurately to GSK scientists and research managers at all levels Working with other statisticians on internal department initiatives, e.g. to develop specific technical or consulting skills, new processes, etc. Reviewing literature and writing simulations to evaluate statistical methods for application to drug discovery problems. Representing our statistics team in collaborations with other internal statistics teams and scientists. Supervising a small team (2-5 people) of statisticians, enhancing their ability to address key scientific questions by providing technical (statistical and scientific) direction to projects and by developing their consulting skills Identifying and contributing statistics methodological expertise within the team through ongoing personal development and collaboration on challenging technical problems GSK's overall R&D strategy focuses on science related to the immune system, the use of human genetics and advanced technologies. These unlock the potential of new areas of science, enabling us to design and develop new classes of medicine and bring them to patients more quickly and cost-effectively. Applications close once position is filled. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MSc or PhD in statistics, biostatistics, or a closely related field with formal statistical training Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong academic record Significant experience as a statistician, collaborating with scientists from other disciplines Strong oral and written English communication skills For Principal Statistician ability to: To apply statistical skills accurately to practical problems To collaborate well with statisticians and scientists from other disciplines To explain novel and standard statistical methods clearly to scientific colleagues To identify existing or develop new statistical methods to improve the design, analysis, and interpretation of scientific studies To evaluate, recommend, and implement statistical tools for addressing scientific problems To learn new statistics skills quickly and independently For Leader demonstrated ability to: Identify existing or develop new statistical methods to improve the design, analysis, and interpretation of scientific studies Evaluate, recommend, and implement statistical tools for addressing scientific problems Deliver statistical consulting (design, analysis, and interpretation of studies) to scientists in multiple disciplines Take a leadership role in multi-disciplinary teams Build and maintain relationships with customer groups Drive the adoption of statistical best practice within Research & Development Lead initiatives within a statistics team to develop internal capability Develop junior staff through mentoring or supervision Interest in continually learning and applying new statistical skills Motivated to continue learning new statistical skills and to solve challenging problems in drug discovery Practical understanding of at least some of the following statistics topics: Experimental design, mixed models, Bayesian methods, linear and nonlinear regression, repeated measures, machine learning algorithms, analysis of high-dimensional data Genomics, molecular biology, disease biology, and cellular, tissue, and animal models Why GSK? At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we're getting ready to deliver the most significant change to our company in over 20 years. We're on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health. With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We'll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years . All of this depends on our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary..... click apply for full job details
Sep 21, 2022
Full time
Site Name: UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Aug Our team collaborates with top laboratory and clinical scientists to advance exciting, innovative ideas in drug discovery. We design experiments, analyze data, and visualize results for projects that range from small studies with single endpoints to high-dimensional genomic data.We use traditional statistical methods and modern machine learning algorithms, design experiments to develop new technologies and analyze data to identify biomarkers for clinical trials. Our work is varied and challenging with the common goal to advance the science of human health. To succeed, team members need good technical and communication skills, the desire to develop their statistical and scientific knowledge continually, and the ability to develop practical solutions and apply statistical techniques in creative ways. Successful candidates will be innovative, pragmatic, and flexible, thriving in a dynamic, collegial environment with frequent new challenges and excellent opportunities to develop and succeed. In this role, you will be responsible for providing statistical consulting for 1-2 scientific research areas within GSK. Key Responsibilities include, but are not limited to (Varies on position level): Collaborating closely with GSK scientists and scientific management to address important drug discovery questions with statistical methods Identifying key scientific challenges that can be addressed with statistical methods and proposing how to do so Applying existing statistical methods or developing new ones to address scientific problems Designing experiments and ensuring experiments are designed to address scientific questions clearly and accurately Analyzing data and ensuring the results of statistical analyses can be relied upon for making important drug discovery decisions around targets, molecules, and technologies Communicating statistical concepts, design recommendations, and the results of statistical analyses clearly and accurately to GSK scientists and research managers at all levels Working with other statisticians on internal department initiatives, e.g. to develop specific technical or consulting skills, new processes, etc. Reviewing literature and writing simulations to evaluate statistical methods for application to drug discovery problems. Representing our statistics team in collaborations with other internal statistics teams and scientists. Supervising a small team (2-5 people) of statisticians, enhancing their ability to address key scientific questions by providing technical (statistical and scientific) direction to projects and by developing their consulting skills Identifying and contributing statistics methodological expertise within the team through ongoing personal development and collaboration on challenging technical problems GSK's overall R&D strategy focuses on science related to the immune system, the use of human genetics and advanced technologies. These unlock the potential of new areas of science, enabling us to design and develop new classes of medicine and bring them to patients more quickly and cost-effectively. Applications close once position is filled. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MSc or PhD in statistics, biostatistics, or a closely related field with formal statistical training Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong academic record Significant experience as a statistician, collaborating with scientists from other disciplines Strong oral and written English communication skills For Principal Statistician ability to: To apply statistical skills accurately to practical problems To collaborate well with statisticians and scientists from other disciplines To explain novel and standard statistical methods clearly to scientific colleagues To identify existing or develop new statistical methods to improve the design, analysis, and interpretation of scientific studies To evaluate, recommend, and implement statistical tools for addressing scientific problems To learn new statistics skills quickly and independently For Leader demonstrated ability to: Identify existing or develop new statistical methods to improve the design, analysis, and interpretation of scientific studies Evaluate, recommend, and implement statistical tools for addressing scientific problems Deliver statistical consulting (design, analysis, and interpretation of studies) to scientists in multiple disciplines Take a leadership role in multi-disciplinary teams Build and maintain relationships with customer groups Drive the adoption of statistical best practice within Research & Development Lead initiatives within a statistics team to develop internal capability Develop junior staff through mentoring or supervision Interest in continually learning and applying new statistical skills Motivated to continue learning new statistical skills and to solve challenging problems in drug discovery Practical understanding of at least some of the following statistics topics: Experimental design, mixed models, Bayesian methods, linear and nonlinear regression, repeated measures, machine learning algorithms, analysis of high-dimensional data Genomics, molecular biology, disease biology, and cellular, tissue, and animal models Why GSK? At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we're getting ready to deliver the most significant change to our company in over 20 years. We're on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health. With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We'll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years . All of this depends on our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary..... click apply for full job details
Site Name: USA - Pennsylvania - Upper Providence, Collegeville TSA, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Marietta Posted Date: Aug Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines. Oncology Biomarker Programming is committed to supporting the development of novel Oncology therapies via our exploratory Biomarker work. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations : Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Creation of biomarker analysis datasets from a variety of file and formats from either internal or external labs/vendors. The candidate should be comfortable working with a diverse collection of data files in terms of the type (depending on the assays/platform used to generate the data), data format and size. Creation of graphs and tables related to biomarker data primarily for exploratory investigations (hypothesis generation or evaluation) with analysis requirements that may change throughout the life of the project. Automation of data creation, graphs, tables and certain Statistical analyses using R scripts and developing R-Shiny apps for delivering automated analysis solutions for end users. Act as a subject matter expert and work as a guide within own discipline to investigate new technology as directed. Provide technical contribution to complex tasks. Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes. Apply learning from previous activities to result in quicker and more efficient completion of the current task. Ability to closely collaborate with major stakeholders in Translational Statistics, GSK's Experimental Medicine Unit, Clinical Programming and Data Management. Share learnings with peers and contribute to internal technical discussions/forums. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc or higher in mathematics, statistics, data science, computer science or related discipline. Clinical Programming experience, with a thorough understanding of the end to end clinical trial process. Recognized expertise in R, SAS programming, and script/macro code development. Understanding of other products such as R-Shiny, Python, Power BI, JMP, SAS/GRAPH, SAS Output Delivery System. Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Demonstrated ability to collaborate across functions. A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11). Demonstrated knowledge of and experience in the application of CDISC data and standards Preferred Qualifications If you have the following characteristics, it would be a plus: Working knowledge of relevant therapeutic area such as oncology Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Deliver presentations with clarity in internal forums and/or external professional industry meetings Able to explain technical approaches to peers and non-technical colleagues/settings Oncology Data Strategy is committed to supporting the development of novel Oncology therapies in collaboration with Disease Area Strategy. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumor Cell Targeting. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations : Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Application of Programming and Data Science techniques to integrate Historical Trial Data (HTD) of various formats from numerous source platforms and systems. Collaborate with our Real World Evidence (RWE) team to incorporate RWD into the Oncology Data Strategy initiatives. Contribute to building a robust infrastructure for storage of integrated data and subsequent data lake. Invest in developing knowledge in internal and external regulations of data reuse. Automation of data creation for delivering analysis solutions for end users. Participate/Lead the planning and execution of multiple data strategy programming activities. Provide technical contribution to complex tasks. Work as a lead within own discipline to investigate new technology as directed. Apply learning from previous activities to result in quicker and more efficient completion of the current task. Ability to closely collaborate with major stakeholders in Disease Strategy, RWE, Clinical Programming and Statistics, and Data Strategy and Data Engineering. Share learnings with peers and contribute to internal technical discussions/forums. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc or higher in mathematics, statistics, data science, computer science or related discipline. Clinical Programming experience, with an understanding of the end to end clinical trial process. Experience with data pooling and clinical data reuse. Experience with RWE databases (for example, FlatIron, Tempus). Demonstrated experience in data integration and database design. Recognized expertise in R, SAS programming, and script/macro code development. Understanding of other products such as R-Shiny, Python, Power BI, JMP, SAS/GRAPH, SAS Output Delivery System. Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable. Demonstrated ability to collaborate across functions. Experience leading multiple projects. Able to explain technical approaches to peers and non-technical colleagues/settings. A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11). Demonstrated knowledge of and experience in the application of CDISC data and standards. Preferred Qualifications If you have the following characteristics, it would be a plus: Working knowledge of relevant therapeutic area such as oncology Takes responsibility for oversight of others work as assigned by manager Experience with writing and applying Metadata Specifications/Derivations Deliver presentations with clarity in internal forums and/or external professional industry meetings Why GSK At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines..... click apply for full job details
Sep 21, 2022
Full time
Site Name: USA - Pennsylvania - Upper Providence, Collegeville TSA, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Marietta Posted Date: Aug Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines. Oncology Biomarker Programming is committed to supporting the development of novel Oncology therapies via our exploratory Biomarker work. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations : Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Creation of biomarker analysis datasets from a variety of file and formats from either internal or external labs/vendors. The candidate should be comfortable working with a diverse collection of data files in terms of the type (depending on the assays/platform used to generate the data), data format and size. Creation of graphs and tables related to biomarker data primarily for exploratory investigations (hypothesis generation or evaluation) with analysis requirements that may change throughout the life of the project. Automation of data creation, graphs, tables and certain Statistical analyses using R scripts and developing R-Shiny apps for delivering automated analysis solutions for end users. Act as a subject matter expert and work as a guide within own discipline to investigate new technology as directed. Provide technical contribution to complex tasks. Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes. Apply learning from previous activities to result in quicker and more efficient completion of the current task. Ability to closely collaborate with major stakeholders in Translational Statistics, GSK's Experimental Medicine Unit, Clinical Programming and Data Management. Share learnings with peers and contribute to internal technical discussions/forums. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc or higher in mathematics, statistics, data science, computer science or related discipline. Clinical Programming experience, with a thorough understanding of the end to end clinical trial process. Recognized expertise in R, SAS programming, and script/macro code development. Understanding of other products such as R-Shiny, Python, Power BI, JMP, SAS/GRAPH, SAS Output Delivery System. Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Demonstrated ability to collaborate across functions. A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11). Demonstrated knowledge of and experience in the application of CDISC data and standards Preferred Qualifications If you have the following characteristics, it would be a plus: Working knowledge of relevant therapeutic area such as oncology Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Deliver presentations with clarity in internal forums and/or external professional industry meetings Able to explain technical approaches to peers and non-technical colleagues/settings Oncology Data Strategy is committed to supporting the development of novel Oncology therapies in collaboration with Disease Area Strategy. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumor Cell Targeting. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations : Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Application of Programming and Data Science techniques to integrate Historical Trial Data (HTD) of various formats from numerous source platforms and systems. Collaborate with our Real World Evidence (RWE) team to incorporate RWD into the Oncology Data Strategy initiatives. Contribute to building a robust infrastructure for storage of integrated data and subsequent data lake. Invest in developing knowledge in internal and external regulations of data reuse. Automation of data creation for delivering analysis solutions for end users. Participate/Lead the planning and execution of multiple data strategy programming activities. Provide technical contribution to complex tasks. Work as a lead within own discipline to investigate new technology as directed. Apply learning from previous activities to result in quicker and more efficient completion of the current task. Ability to closely collaborate with major stakeholders in Disease Strategy, RWE, Clinical Programming and Statistics, and Data Strategy and Data Engineering. Share learnings with peers and contribute to internal technical discussions/forums. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc or higher in mathematics, statistics, data science, computer science or related discipline. Clinical Programming experience, with an understanding of the end to end clinical trial process. Experience with data pooling and clinical data reuse. Experience with RWE databases (for example, FlatIron, Tempus). Demonstrated experience in data integration and database design. Recognized expertise in R, SAS programming, and script/macro code development. Understanding of other products such as R-Shiny, Python, Power BI, JMP, SAS/GRAPH, SAS Output Delivery System. Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable. Demonstrated ability to collaborate across functions. Experience leading multiple projects. Able to explain technical approaches to peers and non-technical colleagues/settings. A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11). Demonstrated knowledge of and experience in the application of CDISC data and standards. Preferred Qualifications If you have the following characteristics, it would be a plus: Working knowledge of relevant therapeutic area such as oncology Takes responsibility for oversight of others work as assigned by manager Experience with writing and applying Metadata Specifications/Derivations Deliver presentations with clarity in internal forums and/or external professional industry meetings Why GSK At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines..... click apply for full job details
Geoff King at RBW Consulting is working with one of the world's leading CRO in the recruitment of multiple Senior & Principal Statistical Programmers as they embark on an exciting new era of Data Science in the world of healthcare and drug discovery. Supported by cutting edge technology and a management team of industry recognised experts this organisation gives you the opportunity to work at the forefront of the pharmaceutical industry by leading assigned trials as part of a specialist, single sponsor team on multiple global studies across phases I - IV. Able to be worked from home across Europe there are fantastic promotional opportunities thanks to the industry leading training and development on offer. Career paths range from line management to subject matter expert and will be tailored specifically to you. With continued plans for expansion and Human Data Science at the forefront of this multi-billion pound company Statistical Programming is integral to everything they do. Therefore, there are opportunities across Europe at both Senior and Principal levels. *Main duties & responsibilities:* * Import data from various sources * Program quality control checks for source data and reporting data issues * Interpret project level requirements and develop programming specifications * Write programming code following established Good Programming Practices * Program SDTM and ADaM datasets * Program to create statistical analysis tables, listing and figures * Validate datasets and all statistical outputs per prescribed gate checks * Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines * Use and promote the use of established standards, SOPs, and standard methodologies * Provide training and mentoring to team members and department staff *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Knowledge of statistics, programming and/or clinical drug development process * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Ability to lead teams and projects and capable of managing at a group level * Degree in computer science or related field and 3 years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Dec 07, 2021
Full time
Geoff King at RBW Consulting is working with one of the world's leading CRO in the recruitment of multiple Senior & Principal Statistical Programmers as they embark on an exciting new era of Data Science in the world of healthcare and drug discovery. Supported by cutting edge technology and a management team of industry recognised experts this organisation gives you the opportunity to work at the forefront of the pharmaceutical industry by leading assigned trials as part of a specialist, single sponsor team on multiple global studies across phases I - IV. Able to be worked from home across Europe there are fantastic promotional opportunities thanks to the industry leading training and development on offer. Career paths range from line management to subject matter expert and will be tailored specifically to you. With continued plans for expansion and Human Data Science at the forefront of this multi-billion pound company Statistical Programming is integral to everything they do. Therefore, there are opportunities across Europe at both Senior and Principal levels. *Main duties & responsibilities:* * Import data from various sources * Program quality control checks for source data and reporting data issues * Interpret project level requirements and develop programming specifications * Write programming code following established Good Programming Practices * Program SDTM and ADaM datasets * Program to create statistical analysis tables, listing and figures * Validate datasets and all statistical outputs per prescribed gate checks * Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines * Use and promote the use of established standards, SOPs, and standard methodologies * Provide training and mentoring to team members and department staff *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Knowledge of statistics, programming and/or clinical drug development process * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Ability to lead teams and projects and capable of managing at a group level * Degree in computer science or related field and 3 years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
*Principal Statistical Scientist - EMEA * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. We currently have an opportunity for an expert Lead Biostatistician to join our Statistical Science team within Biostats and Programming as a Principal Statisitcal Scientist. As a Prin Stat Scientist you will perform a statistical consulting role both internally and externally. Responsibilities include: * Serves as the lead statistician on broad-based projects or complex, multiple protocol programs as required. * Serves as the project manager for Biostatistics contracts -both stand alone and cross divisional. * Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. * Provides scientific strategy consultation to clients for drug or device development planning. * Provides statistical input into corporate initiatives. * Maintains expertise in state-of-the-art data manipulations and statistical analyses. * Represents the department to clients on complex study scientific and design considerations, directly contributing to complex study proposals and bids, representing the department at bid defenses. *Qualifications:* *To be considered for the role, you should have the following Education, Skills and Experience:* * Master's degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 5 years of clinic al trial experience as a statistician; * PH.D. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 3 years of clinical trial experience as a statistician; * Required Knowledge, Skills and Abilities: * * Demonstrated initiative and motivation. * Excellent verbal and written communication skills. * Positive attitude and the ability to work well with others in a multi-disciplinary setting. * Strong knowledge of SAS and clinical biostatistics. * Demonstrated knowledge of the drug development process. * Conversant knowledge of FDA and other Regulatory guidances and regulations. * Demonstrated ability to manage change and uncertainty to optimize positive outcomes. * Must be able to multi task and pay close attention to detail. * Proven performance in leading complex projects. * Good organizational skills with the ability to adapt and adjust to changing priorities. * Strong theoretical background and applied statistical knowledge. * Ability to mentor statisticians with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic area.. * Ability to communicate complex statistical concepts in a multi-disciplinary setting. * Demonstrated knowledge in one or more therapeutic areas. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-AD1
Dec 06, 2021
Full time
*Principal Statistical Scientist - EMEA * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. We currently have an opportunity for an expert Lead Biostatistician to join our Statistical Science team within Biostats and Programming as a Principal Statisitcal Scientist. As a Prin Stat Scientist you will perform a statistical consulting role both internally and externally. Responsibilities include: * Serves as the lead statistician on broad-based projects or complex, multiple protocol programs as required. * Serves as the project manager for Biostatistics contracts -both stand alone and cross divisional. * Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. * Provides scientific strategy consultation to clients for drug or device development planning. * Provides statistical input into corporate initiatives. * Maintains expertise in state-of-the-art data manipulations and statistical analyses. * Represents the department to clients on complex study scientific and design considerations, directly contributing to complex study proposals and bids, representing the department at bid defenses. *Qualifications:* *To be considered for the role, you should have the following Education, Skills and Experience:* * Master's degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 5 years of clinic al trial experience as a statistician; * PH.D. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 3 years of clinical trial experience as a statistician; * Required Knowledge, Skills and Abilities: * * Demonstrated initiative and motivation. * Excellent verbal and written communication skills. * Positive attitude and the ability to work well with others in a multi-disciplinary setting. * Strong knowledge of SAS and clinical biostatistics. * Demonstrated knowledge of the drug development process. * Conversant knowledge of FDA and other Regulatory guidances and regulations. * Demonstrated ability to manage change and uncertainty to optimize positive outcomes. * Must be able to multi task and pay close attention to detail. * Proven performance in leading complex projects. * Good organizational skills with the ability to adapt and adjust to changing priorities. * Strong theoretical background and applied statistical knowledge. * Ability to mentor statisticians with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic area.. * Ability to communicate complex statistical concepts in a multi-disciplinary setting. * Demonstrated knowledge in one or more therapeutic areas. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-AD1
Company description: Qualifications and Experience: Master's degree in Statistics, Biostatistics or related discipline 5-10 years experience in statistical or biostatistical analysis supporting clinical trail operations for the pharma/biotech industry Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and dat...... click apply for full job details
Dec 05, 2021
Full time
Company description: Qualifications and Experience: Master's degree in Statistics, Biostatistics or related discipline 5-10 years experience in statistical or biostatistical analysis supporting clinical trail operations for the pharma/biotech industry Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and dat...... click apply for full job details
*Sr. or Principal Statistical Programmer - FSP* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities* • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required*What we're looking for* • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Dec 03, 2021
Full time
*Sr. or Principal Statistical Programmer - FSP* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities* • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required*What we're looking for* • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Statistician Ashley consulting is currently recruiting for an Senior Statistician to work remotely on a contract basis in either UK or Europe. My client provides a wealth of research knowledge for both biostatistics and operations in the life sciences industries for both software and services. They believe in investing their employees careers with significant professional growth and tr...... click apply for full job details
Dec 03, 2021
Contractor
Statistician Ashley consulting is currently recruiting for an Senior Statistician to work remotely on a contract basis in either UK or Europe. My client provides a wealth of research knowledge for both biostatistics and operations in the life sciences industries for both software and services. They believe in investing their employees careers with significant professional growth and tr...... click apply for full job details
