Director, Pharmacokinetics Home-Based/Hybrid: Europe/UK Decision Sciences - Clinical Pharmacology/Pharmacokinetics Job Profile Summary Perform analysis and reporting of Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives. Responsibilities As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans. Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies. Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients. Provide update to the IQVIA Project Manager on status of project PK/PD deliverables. Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer. Consult and interact with clients, other IQVIA divisions, and third-party vendors. Provide technical training, guidance, and mentorship to lower level and new staff. Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals. Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review. Assist management in implementing strategic initiatives. Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc. Perform other duties as assigned by Clinical Pharmacology Management. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Experience 7 - 10 years of prior relevant experience. Education Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field, or Master's Degree or PharmD in Pharmacy or related field Skills and Abilities Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends Sound knowledge of appropriate PK/PD standards and processes Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements Good coaching and mentoring skills Good problem solving and analytical skills Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills Ability to work within a matrix team environment Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects Ability to interact in a cross-functional and multi-cultural team environment Ability to establish and maintain effective working relationships with coworkers, managers and clients JOIN US! Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do! IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
Dec 18, 2022
Full time
Director, Pharmacokinetics Home-Based/Hybrid: Europe/UK Decision Sciences - Clinical Pharmacology/Pharmacokinetics Job Profile Summary Perform analysis and reporting of Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives. Responsibilities As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans. Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies. Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients. Provide update to the IQVIA Project Manager on status of project PK/PD deliverables. Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer. Consult and interact with clients, other IQVIA divisions, and third-party vendors. Provide technical training, guidance, and mentorship to lower level and new staff. Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals. Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review. Assist management in implementing strategic initiatives. Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc. Perform other duties as assigned by Clinical Pharmacology Management. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Experience 7 - 10 years of prior relevant experience. Education Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field, or Master's Degree or PharmD in Pharmacy or related field Skills and Abilities Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends Sound knowledge of appropriate PK/PD standards and processes Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements Good coaching and mentoring skills Good problem solving and analytical skills Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills Ability to work within a matrix team environment Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects Ability to interact in a cross-functional and multi-cultural team environment Ability to establish and maintain effective working relationships with coworkers, managers and clients JOIN US! Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do! IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
Biostatistician I Swansea Office Based Recruitment commencing from January 2023 onwards! We are looking to grow our Biostatistics team in Swansea with an Academy Program starting in September 2023. Our Swansea Office is home to multiple graduate schemes and has a strong record of producing fantastic experts in their respective fields. This also sets it apart as being a great social environment and its modern city centre, waterfront building makes it a brilliant place to work 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. The role: ICON's Biostatistics Academy is our specially designed program to kickstart your career as a Biostatistician in the Clinical Trials industry. We provide you with everything you need to know about the industry and your role within it through a mixture of instructor-led training, practical experience and mentoring. You will gain technical skills such as Statistical Programming in SAS and creating Statistical Analysis Plans, as well as skills for life such as communication and project management. A dedicated Training Manager will deliver the program and be available for providing support. In return, we are looking for your enthusiasm, inquisitive mind and fresh perspective. Under the supervision of senior biostatisticians, this position is responsible for statistical aspects of clinical research projects. Project responsibilities include: Contributes to the development of statistical analysis plans, including creation of table, figure and listing (TFL) shells. Writes programs to select, manipulate and analyse data, and assists senior biostatistician in interpreting results of these analyses. Prepares statistical summary reports and writes the statistical methods sections of integrated study reports under the supervision of senior biostatisticians. Assists senior biostatistician in statistical aspects of case report form (CRF) design. Establishes and maintains effective working relationships with ICON project team members, including data management personnel, statistical programmers, and clinical research colleagues. Performs additional duties as assigned. You will need: Master's degree or above in Statistics or related field Excellent verbal and written communication skills Ability to work as part of a team Strong attention to detail 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, colour, 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.
Dec 18, 2022
Full time
Biostatistician I Swansea Office Based Recruitment commencing from January 2023 onwards! We are looking to grow our Biostatistics team in Swansea with an Academy Program starting in September 2023. Our Swansea Office is home to multiple graduate schemes and has a strong record of producing fantastic experts in their respective fields. This also sets it apart as being a great social environment and its modern city centre, waterfront building makes it a brilliant place to work 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. The role: ICON's Biostatistics Academy is our specially designed program to kickstart your career as a Biostatistician in the Clinical Trials industry. We provide you with everything you need to know about the industry and your role within it through a mixture of instructor-led training, practical experience and mentoring. You will gain technical skills such as Statistical Programming in SAS and creating Statistical Analysis Plans, as well as skills for life such as communication and project management. A dedicated Training Manager will deliver the program and be available for providing support. In return, we are looking for your enthusiasm, inquisitive mind and fresh perspective. Under the supervision of senior biostatisticians, this position is responsible for statistical aspects of clinical research projects. Project responsibilities include: Contributes to the development of statistical analysis plans, including creation of table, figure and listing (TFL) shells. Writes programs to select, manipulate and analyse data, and assists senior biostatistician in interpreting results of these analyses. Prepares statistical summary reports and writes the statistical methods sections of integrated study reports under the supervision of senior biostatisticians. Assists senior biostatistician in statistical aspects of case report form (CRF) design. Establishes and maintains effective working relationships with ICON project team members, including data management personnel, statistical programmers, and clinical research colleagues. Performs additional duties as assigned. You will need: Master's degree or above in Statistics or related field Excellent verbal and written communication skills Ability to work as part of a team Strong attention to detail 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, colour, 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.
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
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Dec 08, 2022
Full time
Siemens Healthineers is seeking a Pre-market Biostatistician to join our Healthcare Diagnostics business. This is a primarily home-based role with some travel to our site in Llanberis. It comes with an attractive salary and a positive workplace culture. As a Pre-market Biostatistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to t click apply for full job details
Well-renowned Pharma, Hybrid working, Competitive salary. Your new company Are you looking for the next step in your career and want the opportunity to make an impact within a well renowned global Pharma? This company are expanding their biostatistics department and are looking for strong, experienced statisticians. As a company they pull together to make a difference to patients' lives every day by creating life changing medicines through their innovative ideas. You will have the chance to develop your expertise in a supportive and inclusive environment, working alongside like-minded individuals.You have the opportunity to become a Senior Statistician and work within a team of experienced statisticians. The career progression options are incredible, and you would receive a competitive salary with additional company benefits. Your new role You will lead the strategic, statistical thinking and contributions to the study design and execution, regulatory and commercial strategy, as well as reimbursement assessment of the company's products. There are many career options you can pursue for progression including technical pathways, management of global projects or line management. You'll be part of a global team that pulls together to put patients first. ResponsibilitiesReporting to a Director/Senior Director, you will provide statistical expertise in one or more of the following areas: Analyse internal and external information to inform design decisions and the development of decision criteria Support for delivering studies, both internally and externally, all the way from the clinical study protocol to study reports and publications Lead statistical contributions to regulatory submissions and approvals. Contribute to payer and reimbursement assessments. Find opportunities for the application of modelling and simulation to improve study design Identify and apply statistical methodology to improve the process and delivery activities Perform ad hoc and exploratory data analyses Quantify the benefit, risk, value and uncertainty of the emerging product profile Holding CROs accountable for the high-quality standards of their deliverables Represent the company and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues. What you'll need to succeed To succeed in this role, you'll be a Biostatistician with good knowledge of technical and regulatory requirements related to statistical work within the pharmaceutical or healthcare industry. You'll enjoy multitasking, collaborating and have an appetite for solving problems. You will need to be an effective communicator globally, with a strong team focus who enjoys collaborating to achieve the best results.Desirable experience includes: MSc or PhD in Statistics or Mathematics Excellent analytical skills Experience working as a statistician, preferably in pharma/healthcare or other relevant area Diligence - attention to detail and able to handle concurrent projects and activities Excellent verbal and written interpersonal skills and ability to influence partners Experience of drug development, study design and data analysis and interpretation Knowledge of regulatory submission requirement What you'll get in return Hybrid working Competitive salary and additional company benefits Chance to work in a supportive and inclusive environment Work with like-minded individuals Excellent career progression opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Dec 02, 2022
Full time
Well-renowned Pharma, Hybrid working, Competitive salary. Your new company Are you looking for the next step in your career and want the opportunity to make an impact within a well renowned global Pharma? This company are expanding their biostatistics department and are looking for strong, experienced statisticians. As a company they pull together to make a difference to patients' lives every day by creating life changing medicines through their innovative ideas. You will have the chance to develop your expertise in a supportive and inclusive environment, working alongside like-minded individuals.You have the opportunity to become a Senior Statistician and work within a team of experienced statisticians. The career progression options are incredible, and you would receive a competitive salary with additional company benefits. Your new role You will lead the strategic, statistical thinking and contributions to the study design and execution, regulatory and commercial strategy, as well as reimbursement assessment of the company's products. There are many career options you can pursue for progression including technical pathways, management of global projects or line management. You'll be part of a global team that pulls together to put patients first. ResponsibilitiesReporting to a Director/Senior Director, you will provide statistical expertise in one or more of the following areas: Analyse internal and external information to inform design decisions and the development of decision criteria Support for delivering studies, both internally and externally, all the way from the clinical study protocol to study reports and publications Lead statistical contributions to regulatory submissions and approvals. Contribute to payer and reimbursement assessments. Find opportunities for the application of modelling and simulation to improve study design Identify and apply statistical methodology to improve the process and delivery activities Perform ad hoc and exploratory data analyses Quantify the benefit, risk, value and uncertainty of the emerging product profile Holding CROs accountable for the high-quality standards of their deliverables Represent the company and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues. What you'll need to succeed To succeed in this role, you'll be a Biostatistician with good knowledge of technical and regulatory requirements related to statistical work within the pharmaceutical or healthcare industry. You'll enjoy multitasking, collaborating and have an appetite for solving problems. You will need to be an effective communicator globally, with a strong team focus who enjoys collaborating to achieve the best results.Desirable experience includes: MSc or PhD in Statistics or Mathematics Excellent analytical skills Experience working as a statistician, preferably in pharma/healthcare or other relevant area Diligence - attention to detail and able to handle concurrent projects and activities Excellent verbal and written interpersonal skills and ability to influence partners Experience of drug development, study design and data analysis and interpretation Knowledge of regulatory submission requirement What you'll get in return Hybrid working Competitive salary and additional company benefits Chance to work in a supportive and inclusive environment Work with like-minded individuals Excellent career progression opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
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
Manager, Biostatistics - FSP team 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 • 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 • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. 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.
Sep 22, 2022
Full time
Manager, Biostatistics - FSP team 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 • 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 • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. 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.
JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health 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. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Sep 22, 2022
Full time
JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health 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. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy , which enables the non-invasive collection and analysis of biomarkers in exhaled breath for early disease detection and precision medicine. We are currently seeking a Senior Biostatistician with clinical research and biomarker discovery experience to be a member of our Clinical and Translational Science Department. The candidate will contribute to the mission of the company by providing input into clinical study designs and trial protocols and will ensure that data analysis and interpretation of results are statistically sound and meet the desired study objectives. The Senior Biostatistician will work in a cross-functional team to support Owlstone s clinical test development and customer services business. Key responsibilities: Perform appropriate statistical analyses at all phases of the project, from clinical protocol development and study design through final analysis and reporting of results Evaluate clinical research studies and prepare statistical analysis plans that provide sound approaches to support a continuum of study goals, from biomarker discovery through clinical test development Apply appropriate statistical methodologies to analyze the data, including, but not limited to, hypothesis testing, regression models, multivariate analyses, machine learning, and network-based analyses Program and analyze data using Python or R; demonstrate good programming practices through proper documentation and commenting; perform appropriate QA to ensure accuracy and consistency of results Effectively communicate statistical methods and results to cross-functional team members, clinical collaborators, and others with a variety of technical expertise (including lay audience) Maintaining technical knowledge and skills appropriate for the role, including staying current with innovative statistical methodologies that are relevant to clinical research Requirements Technical Competencies: A thorough understanding of sample size, study power, precision, and their application in clinical trials and/or observational studies Proficient in translating clinical research questions into testable hypotheses Adept in communicating the assumptions, limitations, and advantages or disadvantages of statistical methods and describing preferred alternatives when key assumptions are not met Working proficiency in Python (to the level of package writing) or R (capable of implementing statistical or computational methods) Demonstrated ability to take initiative and be proactive in your approach to work, with an independent, creative, and open mindset Desirable Experience: Statistical experience working with CROs or the biopharmaceutical industry Application of statistical design and analysis for biomarker discovery and validation Experience with metabolomics (or other omics) data from clinical or epidemiologic studies Experience working closely with clinical biologists and translational scientists to analyze and interpret clinical datasets Strong publication record or other demonstrable track record of performance and collaboration Familiarity with IRB/ethics and regulatory documentation Qualifications: PhD or equivalent combination of education, training and experience in (bio) statistics or a related discipline, preferably with demonstrable experience working in a clinical, biomedical, or commercial environment
Sep 22, 2022
Full time
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy , which enables the non-invasive collection and analysis of biomarkers in exhaled breath for early disease detection and precision medicine. We are currently seeking a Senior Biostatistician with clinical research and biomarker discovery experience to be a member of our Clinical and Translational Science Department. The candidate will contribute to the mission of the company by providing input into clinical study designs and trial protocols and will ensure that data analysis and interpretation of results are statistically sound and meet the desired study objectives. The Senior Biostatistician will work in a cross-functional team to support Owlstone s clinical test development and customer services business. Key responsibilities: Perform appropriate statistical analyses at all phases of the project, from clinical protocol development and study design through final analysis and reporting of results Evaluate clinical research studies and prepare statistical analysis plans that provide sound approaches to support a continuum of study goals, from biomarker discovery through clinical test development Apply appropriate statistical methodologies to analyze the data, including, but not limited to, hypothesis testing, regression models, multivariate analyses, machine learning, and network-based analyses Program and analyze data using Python or R; demonstrate good programming practices through proper documentation and commenting; perform appropriate QA to ensure accuracy and consistency of results Effectively communicate statistical methods and results to cross-functional team members, clinical collaborators, and others with a variety of technical expertise (including lay audience) Maintaining technical knowledge and skills appropriate for the role, including staying current with innovative statistical methodologies that are relevant to clinical research Requirements Technical Competencies: A thorough understanding of sample size, study power, precision, and their application in clinical trials and/or observational studies Proficient in translating clinical research questions into testable hypotheses Adept in communicating the assumptions, limitations, and advantages or disadvantages of statistical methods and describing preferred alternatives when key assumptions are not met Working proficiency in Python (to the level of package writing) or R (capable of implementing statistical or computational methods) Demonstrated ability to take initiative and be proactive in your approach to work, with an independent, creative, and open mindset Desirable Experience: Statistical experience working with CROs or the biopharmaceutical industry Application of statistical design and analysis for biomarker discovery and validation Experience with metabolomics (or other omics) data from clinical or epidemiologic studies Experience working closely with clinical biologists and translational scientists to analyze and interpret clinical datasets Strong publication record or other demonstrable track record of performance and collaboration Familiarity with IRB/ethics and regulatory documentation Qualifications: PhD or equivalent combination of education, training and experience in (bio) statistics or a related discipline, preferably with demonstrable experience working in a clinical, biomedical, or commercial environment
Working in ICON Strategic Solutions is more than a job, it s a calling for people who care and have passion for improving patients lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you. Responsibilities As Senior Biostatistician, you will provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs. In this role, you will be also responsible to: Services rendered in adherence to applicable SOPs, WIs, policies, local regulatory requirements, etc. Appropriate application of basic statistical methods and generation of accurate and reproducible results. Produce clear, concise, well-organized, and error-free analysis programs and statistical reporting content. Provide more complex analyses with limited oversight from project statisticians. Services rendered comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Services align with relevant regulatory guidance. Documents, specifications, programs, and macros are consistent and comply with project and company standards. Deliverables comply with best practices for Data Integrity. Document projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories. Provide experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communications support. Deliver and execute individual project responsibilities such as meetings with necessary project team members, defining research goals and critical questions, exploratory analyses and visualization, and reporting activities.Support provided for multiple clinical or non-clinical projects Establish and maintain effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Qualifications Requirements: Master's or PhD Degree in Statistics or related field with 3 years or more working on clinical trials as a Biostatistician Thorough understanding of statistical principles Knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas Good written and oral communication skills including grammatical/technical writing skills Experience in with SAS programming & knowledge of SAS procedures and other statistical software Hands on experience in working with CDISC (SDTM / ADaM) Standards. What we offer : Fully home based role within the EMEA region. Full time permanent position Part of a TOP 5 CRO (ICON Clinical), working within ICON ISS Unit (largest FSP unit) on FSP Basis for a well-known global biotech company. Attractive compensation package & benefits; trainings and career development opportunities. Benefits of Working in ICON Strategic Solutions: Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, 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.
Jul 09, 2022
Full time
Working in ICON Strategic Solutions is more than a job, it s a calling for people who care and have passion for improving patients lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you. Responsibilities As Senior Biostatistician, you will provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs. In this role, you will be also responsible to: Services rendered in adherence to applicable SOPs, WIs, policies, local regulatory requirements, etc. Appropriate application of basic statistical methods and generation of accurate and reproducible results. Produce clear, concise, well-organized, and error-free analysis programs and statistical reporting content. Provide more complex analyses with limited oversight from project statisticians. Services rendered comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Services align with relevant regulatory guidance. Documents, specifications, programs, and macros are consistent and comply with project and company standards. Deliverables comply with best practices for Data Integrity. Document projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories. Provide experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communications support. Deliver and execute individual project responsibilities such as meetings with necessary project team members, defining research goals and critical questions, exploratory analyses and visualization, and reporting activities.Support provided for multiple clinical or non-clinical projects Establish and maintain effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Qualifications Requirements: Master's or PhD Degree in Statistics or related field with 3 years or more working on clinical trials as a Biostatistician Thorough understanding of statistical principles Knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas Good written and oral communication skills including grammatical/technical writing skills Experience in with SAS programming & knowledge of SAS procedures and other statistical software Hands on experience in working with CDISC (SDTM / ADaM) Standards. What we offer : Fully home based role within the EMEA region. Full time permanent position Part of a TOP 5 CRO (ICON Clinical), working within ICON ISS Unit (largest FSP unit) on FSP Basis for a well-known global biotech company. Attractive compensation package & benefits; trainings and career development opportunities. Benefits of Working in ICON Strategic Solutions: Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, 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.