Associate Director, Biostatistics FSP
- United States
Posted 6 days ago
About the role
Who Are You?
As an Associate Director of Biostatistics, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience and utilize advanced statistical methods in their Global Therapeutic Statistics group.
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 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:
Our Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
ShortDescriptionStr
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
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 related quantitative discipline; PhD preferred
- 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry Solid recent experience (
- 3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review
- Strong knowledge of adaptive design, group sequential and statistical methods of count data
- Prior experience on Hematology studies preferred
- Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
- Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions
- Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
- Excellent and effective communication skills (clear, concise, and professional) and a bility to interact effectively with cross-functional stakeholders and external partners
- Strong organizational and project management skills
- Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables
InternalQualificationsStr
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 related quantitative discipline; PhD preferred
- 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry Solid recent experience (
- 3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review
- Strong knowledge of adaptive design, group sequential and statistical methods of count data
- Prior experience on Hematology studies preferred
- Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
- Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions
- Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
- Excellent and effective communication skills (clear, concise, and professional) and a bility to interact effectively with cross-functional stakeholders and external partners
- Strong organizational and project management skills
- Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables
InternalResponsibilitiesStr
Your responsibilities will include:
- Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
- Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
- Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
- Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
- Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
- Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
- Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery
ExternalResponsibilitiesStr
Your responsibilities will include:
- Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
- Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
- Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
- Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
- Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
- Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
- Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery