Senior Director, Biostatistics

Role: Senior Director, Biostatistics, leading a team supporting drug development activities across Phases I-IV. Objectives include guiding study design, applying innovative statistical methods, analyzing and interpreting data, and supporting regulatory interactions. Responsibilities encompass overseeing statistical content, coordinating with CROs and external vendors, and contributing to regulatory submissions. Requirements: Ph.D. in Statistics or Biostatistics with 16+ years of clinical research and drug development experience. Preferred: neuroscience expertise, extensive regulatory agency interaction, and familiarity with clinical trial methodologies for registration and lifecycle management. High-value specifics include involvement in neuroscience-focused therapeutics, clinical trial design, and regulatory compliance. Work setup is hybrid in Waltham, MA, with at least 3 days onsite weekly and up to 15% travel.