About the role
Job Description Who Are You? An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's HTA and launch activities. You are motivated to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview This role is to support our customer's Health Technology Assessment (HTA) and launch activities. Having exposure to this area is a bonus, and will enable collaborating effectively, with colleagues from the different functions involved. Strong statistical skills and a flexible, customer-oriented mindset, but in full adherence to good statistical principles, will make you an asset for this role.
Responsibilities As a Senior Biostatistician, your responsibilities will include:
- Providing statistical support to our customer's launch and HTA activities
- Contributing to the concept, planning and delivery of scientific publications related to new products launched by our customer
- Supporting the planning compilation of HTA dossiers as appropriate
- Support Economic Modelling as appropriate
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
- Understand and follow applicable guidelines in different regions.
- Collaborate with internal and external functions (e.g. CROs, programming clinical development partners, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical practices
Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Master’s degree in statistics or a related discipline. Ph.D. is desirable.
- 5+ years supporting drug development or launch/post-marketing activities in the Pharmaceutical or Biotechnology industry.
- Experience with launch/HTA activities and/or economic modelling is strongly desired.
- Good SAS and/or R programming skills with application to these fields for generation and QC of deliverables and exploratory activities/modelling
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Full commitment to driving effective delivery and contributing to the strategic goals of the customer's project/product teams
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- If you possess German language skill at a native or near-native level, this will create additional opportunities for involvement in the customer's German HTA dossiers.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
About the role
Job Description Who Are You? An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's HTA and launch activities. You are motivated to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview This role is to support our customer's Health Technology Assessment (HTA) and launch activities. Having exposure to this area is a bonus, and will enable collaborating effectively, with colleagues from the different functions involved. Strong statistical skills and a flexible, customer-oriented mindset, but in full adherence to good statistical principles, will make you an asset for this role.
Responsibilities As a Senior Biostatistician, your responsibilities will include:
- Providing statistical support to our customer's launch and HTA activities
- Contributing to the concept, planning and delivery of scientific publications related to new products launched by our customer
- Supporting the planning compilation of HTA dossiers as appropriate
- Support Economic Modelling as appropriate
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
- Understand and follow applicable guidelines in different regions.
- Collaborate with internal and external functions (e.g. CROs, programming clinical development partners, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical practices
Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Master’s degree in statistics or a related discipline. Ph.D. is desirable.
- 5+ years supporting drug development or launch/post-marketing activities in the Pharmaceutical or Biotechnology industry.
- Experience with launch/HTA activities and/or economic modelling is strongly desired.
- Good SAS and/or R programming skills with application to these fields for generation and QC of deliverables and exploratory activities/modelling
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Full commitment to driving effective delivery and contributing to the strategic goals of the customer's project/product teams
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- If you possess German language skill at a native or near-native level, this will create additional opportunities for involvement in the customer's German HTA dossiers.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.