Associate Director/Director, Biostatistics

Role Summary

Provide statistical strategy, design, execution, and reporting of clinical trials across development programs as Associate Director/Director, Biostatistics. Work closely with the Head of Biometrics and oversee CRO biometrics to ensure timely execution of trials.

Responsibilities

• Responsible for the statistical strategy for one or more clinical programs/studies and for providing oversight of CRO biometrics deliverables.
• Support clinical development team to enable robust study design and execution with a focus on innovative and efficient quantitative decision making.
• Contribute to clinical protocol development, including design evaluations and authoring of protocol statistical sections.
• Work with study team to develop SAP, data specification, TLF shells, and data monitoring charters etc. and generate TLFs and perform ad hoc analysis as needed.
• Review CRF design, data management plan, and data transfer plans to ensure data collection meet the trial objectives and requirements of statistical analyses.
• Specify randomization schedules and test their implementations as needed.
• Contribute to the review and interpretation of data analyses from clinical trials and to the development of CSRs, regulatory documents and support publications, manuscripts, posters and abstracts.
• Support regulatory submissions and interactions with regulatory agencies.
• Provide requirements and oversight to statistical programmers.
• Works collaboratively and communicates effectively with Statistical programming, Data Management, clinical operations, clinical development, Regulatory and other functions.

Qualifications

• Ph.D. in statistics or biostatistics with a minimum of 7 years’ post-doctoral experience in pharmaceutical/biotech industry with prior project leadership or equivalent experience.
• In-depth knowledge of statistical methods and trial designs for rare disease and/or gene and cell therapy clinical trials.
• Extensive experience in statistical simulations, Bayesian statistical design and analysis and experience in observational studies and/or real world data (RW) are desirable.
• Extensive experience in NDA/BLAs, MAAs and other regulatory interactions preferred.
• Strong knowledge of FDA and ICH regulations and guidelines, experience and knowledge of gene/cell therapy are desirable.
• Proficient in SAS and R programming.
• Strong knowledge of data standards, including CDASH, SDTM, and ADaM.
• Must be self-motivated, and able to work independently and effectively with colleagues and vendors and demonstrate excellent verbal and written communication skills.
• Ability to prioritize and manage timelines and shifting priorities within a fast-paced company environment.
• Ability to build cross-functional relationships and work collaboratively across functions.

Additional Requirements

• Onsite requirements: Candidates are expected to come onsite approximately 2 days per week.