Director, Biostatistics

Role: Lead biostatistics for large, late-phase clinical development programs, focusing on trial design, analysis, and regulatory support. Responsibilities: develop innovative trial designs, author statistical protocols and analysis plans, review randomization schemas, collaborate on data collection tools, guide ongoing trial conduct, and support regulatory submissions globally. Also involves interpreting data results, contributing to regulatory documents, and representing the company in interactions with regulators and key stakeholders. Requirements: Ph.D. in Statistics or Biostatistics with 8-10+ years in pharmaceutical statistics, proven experience with late-phase (Phase 2/3) studies, expertise in Bayesian and adaptive trial designs, and proficiency in SAS and R. Preferred: experience supporting NDA/MAA submissions, conducting trial simulations, and familiarity with RNAi therapeutics. HighValue: late-phase global clinical trials, regulatory submissions, Bayesian/adaptive designs, RNAi platform. Collaboration: cross-functional with Clinical Development, Regulatory, Data Management, and Medical Affairs. WorkSetup: not specified; likely hybrid or office-based based on typical senior biostatistics roles.