Phastar
Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, "The Phastar Discipline", has led us to build a reputation for outstanding quality. With this as our core focus, we're looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. What's more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you'll also be helping to save the planet! THE ROLE Work as a statistician on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. Acting as lead statistician within a reporting team environment, being responsible for statistical aspects of reporting out study results. Working as a global lead statistician across multiple studies, overseeing more junior leads and supporting regulatory interactions. Preparing randomisation schedules and acting as the unblinded statistician on reporting teams. Acting as a statistical consultant to pharmaceutical or biotech companies. Excellent team work ethos, and willingness to help others. Potential to have line management responsibilities. Responsibilities Employees may be required to perform some or all of the following: Program and validate primary efficacy datasets Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation Liaise with clients to propose alternatives or additional analyses if needed Develop and validate macros for statistical analyses and figures Perform stage 3 QC Create, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc Write SCS/SCE or ISS/ISE SAPs under supervision; DSMB SAPs and Charters under supervision Perform QC of SAP text and develop standard SAP text and templates to be used within the company Quality Control of TLF shells Lead review process of shells with medical writing and other stakeholders Create or adjust project level, therapeutic area level or standard templates Write statistical section of protocol for simple study design Conduct independent critical protocol review Manage day-to-day workload to ensure project deliverables are met Awareness of CDISC standards Consult with clinical scientists to decide on best approach for sample size calculation, and execution Perform QC of sample size calculations Perform more complex simulations Create more complex randomisation schemes and QC of dummy randomisation schemes Work as unblinded lead reporting statistician producing unblinded outputs Distribute and communicate interim analyses to appropriate stakeholders Coordinate and lead clinical interpretation meetings Complete clinical trial transparency forms Write CSR text as required Review of clinical study reports for accuracy Archive study documentation following instructions in supplied SOPs Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work Implement Good Clinical Practice and adhere to regulatory requirements at all times Lead a team for furthering statistical research Develop and deliver company-wide training Act as a Study Project Lead, managing resources and timelines Work independently as a statistical lead on behalf of other companies Attend and input to company resourcing meetings Create, review and update processes and SOPs Take responsibility for study compliance Qualifications PhD or MSc in Biostatistics or related discipline Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements. APPLY NOW With the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We're committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, "The Phastar Discipline", has led us to build a reputation for outstanding quality. With this as our core focus, we're looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. What's more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you'll also be helping to save the planet! THE ROLE Work as a statistician on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. Acting as lead statistician within a reporting team environment, being responsible for statistical aspects of reporting out study results. Working as a global lead statistician across multiple studies, overseeing more junior leads and supporting regulatory interactions. Preparing randomisation schedules and acting as the unblinded statistician on reporting teams. Acting as a statistical consultant to pharmaceutical or biotech companies. Excellent team work ethos, and willingness to help others. Potential to have line management responsibilities. Responsibilities Employees may be required to perform some or all of the following: Program and validate primary efficacy datasets Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation Liaise with clients to propose alternatives or additional analyses if needed Develop and validate macros for statistical analyses and figures Perform stage 3 QC Create, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc Write SCS/SCE or ISS/ISE SAPs under supervision; DSMB SAPs and Charters under supervision Perform QC of SAP text and develop standard SAP text and templates to be used within the company Quality Control of TLF shells Lead review process of shells with medical writing and other stakeholders Create or adjust project level, therapeutic area level or standard templates Write statistical section of protocol for simple study design Conduct independent critical protocol review Manage day-to-day workload to ensure project deliverables are met Awareness of CDISC standards Consult with clinical scientists to decide on best approach for sample size calculation, and execution Perform QC of sample size calculations Perform more complex simulations Create more complex randomisation schemes and QC of dummy randomisation schemes Work as unblinded lead reporting statistician producing unblinded outputs Distribute and communicate interim analyses to appropriate stakeholders Coordinate and lead clinical interpretation meetings Complete clinical trial transparency forms Write CSR text as required Review of clinical study reports for accuracy Archive study documentation following instructions in supplied SOPs Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work Implement Good Clinical Practice and adhere to regulatory requirements at all times Lead a team for furthering statistical research Develop and deliver company-wide training Act as a Study Project Lead, managing resources and timelines Work independently as a statistical lead on behalf of other companies Attend and input to company resourcing meetings Create, review and update processes and SOPs Take responsibility for study compliance Qualifications PhD or MSc in Biostatistics or related discipline Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements. APPLY NOW With the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We're committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
ZSL London Zoo
Interim Health and Safety Manager (12 Months Fixed-Term Contract) Location: London Department (and Section): Business Services - Estates and Master Planning - Health & Safety and Security Level: Management Position Type: Full-Time / Fixed Term Contract Salary: £44,454 - £49,477 per annum (Inclusive of London Weighting) Enhancements: London Weighting Overview We're ZSL, an international conservation charity. Through our unrivalled animal experts in our two zoos (London Zoo and Whipsnade Zoo), the work of our pioneering scientists, our dedicated conservationists, our purpose is to inspire, inform and empower people to stop wild animals going extinct. Our vision is a world where wildlife thrives and we're working every day to achieve this. From investigating the health threats facing animals, to helping people and wildlife live alongside each other, we are committed to bringing wildlife back from the brink of extinction. Role Profile ZSL has a 12-month fixed term (Maternity Cover) position available for a Health & Safety Manager to manage ZSL's Health and Safety function both at ZSL London Zoo, ZSL Whipsnade Zoo and our conservation and science projects. The successful candidate will look to continually improve systems, compliance and culture within the organisation and will ensure that guidance, training, and support is given at all levels. Main Duties and Responsibilities Oversee the development, review and implementation of health and safety policies and procedures taking into account current legislation, guidance and best practice Support the Principal Lead of Estates and Master-planning in the development of emergency response and business continuity plans, working with relevant stakeholders to rehearse the arrangements Work with the Training & Organisational Development team to develop and review the provision and implementation of health and safety training Oversee the provision of relevant occupational health screening & vaccinations across the UK operations, working with HR to ensure that appropriate follow up action is taken Manage the incident reporting and proportionate investigation of any incidents across the organisation. Collate and curate data for monthly and annual reports and any other reports required on an ad hoc basis Contribute to and participate in senior management team meetings and the health and safety working group Cover 'on call' duties for emergencies and zoo duty manager shifts as required and act in a Silver Command role for major incidents. Influence and promote a positive Health and Safety and Security culture Person Specification NEBOSH Diploma or NVQ Level 5 in Occupational Health and Safety, other relevant qualification. Previous experience of managing a team across multiple locations Demonstrable experience of applying UK safety standards outside of the UK Experience of dealing with major incidents Ability to work with all departments across ZSL and to have a practical approach to diverse working practices Analytical approach with experience of using data to identify accident trends and root causes What do we offer? "Work Your Way": We empower people to work from where they work best. We believe work is something we do and not a place we go. Our offices have become important places for collaboration and social connection but are no longer our main place of work. You will have access to a blended program of Wellbeing initiatives, including confidential access to our 24/7 Employee Assistance Program as well as regular webinars and activities around mental, physical, social, and financial wellbeing. The opportunity to be part of an organisation that is committed to improving diversity and inclusion. Other benefits include 25 days holiday, life assurance, stakeholder pension (employer contribution is matched up to 12%), complimentary zoo tickets with a 30% discount in shops and online, subsidised canteen, enhanced paternity and maternity leave, season ticket loan, cycle to work scheme, subsidised gym membership and access to a wide range of learning and development opportunities. Ultimately, you'll know that you'll help us to inspire, inform and empower people to stop wildlife going extinct. Closing Date: Midnight (23:59) on Sunday 12th December 2021 The Zoological Society of London is a charity registered in England and Wales: no. 208728 . To Apply and for more information: If you would like to find out more about this position and to apply, please click the button to be directed to our website. No agencies please.
Interim Health and Safety Manager (12 Months Fixed-Term Contract) Location: London Department (and Section): Business Services - Estates and Master Planning - Health & Safety and Security Level: Management Position Type: Full-Time / Fixed Term Contract Salary: £44,454 - £49,477 per annum (Inclusive of London Weighting) Enhancements: London Weighting Overview We're ZSL, an international conservation charity. Through our unrivalled animal experts in our two zoos (London Zoo and Whipsnade Zoo), the work of our pioneering scientists, our dedicated conservationists, our purpose is to inspire, inform and empower people to stop wild animals going extinct. Our vision is a world where wildlife thrives and we're working every day to achieve this. From investigating the health threats facing animals, to helping people and wildlife live alongside each other, we are committed to bringing wildlife back from the brink of extinction. Role Profile ZSL has a 12-month fixed term (Maternity Cover) position available for a Health & Safety Manager to manage ZSL's Health and Safety function both at ZSL London Zoo, ZSL Whipsnade Zoo and our conservation and science projects. The successful candidate will look to continually improve systems, compliance and culture within the organisation and will ensure that guidance, training, and support is given at all levels. Main Duties and Responsibilities Oversee the development, review and implementation of health and safety policies and procedures taking into account current legislation, guidance and best practice Support the Principal Lead of Estates and Master-planning in the development of emergency response and business continuity plans, working with relevant stakeholders to rehearse the arrangements Work with the Training & Organisational Development team to develop and review the provision and implementation of health and safety training Oversee the provision of relevant occupational health screening & vaccinations across the UK operations, working with HR to ensure that appropriate follow up action is taken Manage the incident reporting and proportionate investigation of any incidents across the organisation. Collate and curate data for monthly and annual reports and any other reports required on an ad hoc basis Contribute to and participate in senior management team meetings and the health and safety working group Cover 'on call' duties for emergencies and zoo duty manager shifts as required and act in a Silver Command role for major incidents. Influence and promote a positive Health and Safety and Security culture Person Specification NEBOSH Diploma or NVQ Level 5 in Occupational Health and Safety, other relevant qualification. Previous experience of managing a team across multiple locations Demonstrable experience of applying UK safety standards outside of the UK Experience of dealing with major incidents Ability to work with all departments across ZSL and to have a practical approach to diverse working practices Analytical approach with experience of using data to identify accident trends and root causes What do we offer? "Work Your Way": We empower people to work from where they work best. We believe work is something we do and not a place we go. Our offices have become important places for collaboration and social connection but are no longer our main place of work. You will have access to a blended program of Wellbeing initiatives, including confidential access to our 24/7 Employee Assistance Program as well as regular webinars and activities around mental, physical, social, and financial wellbeing. The opportunity to be part of an organisation that is committed to improving diversity and inclusion. Other benefits include 25 days holiday, life assurance, stakeholder pension (employer contribution is matched up to 12%), complimentary zoo tickets with a 30% discount in shops and online, subsidised canteen, enhanced paternity and maternity leave, season ticket loan, cycle to work scheme, subsidised gym membership and access to a wide range of learning and development opportunities. Ultimately, you'll know that you'll help us to inspire, inform and empower people to stop wildlife going extinct. Closing Date: Midnight (23:59) on Sunday 12th December 2021 The Zoological Society of London is a charity registered in England and Wales: no. 208728 . To Apply and for more information: If you would like to find out more about this position and to apply, please click the button to be directed to our website. No agencies please.
