Associate Director, Biostatistics

Role: Associate Director, Biostatistics supporting clinical development programs for a biopharma focused on rare neuroendocrine diseases. Responsibilities include serving as statistical lead for studies, contributing to study design, statistical analysis plans, and regulatory submissions, and collaborating with cross-functional teams on study strategy, data review, and interim analyses. The role involves vendor oversight and supporting high-quality, compliant analysis outputs for INDs, NDAs, and other regulatory filings. Qualifications: PhD in Statistics or Biostatistics with 5+ years (PhD) or MS with 8+ years of relevant experience, proficiency in SAS and R, knowledge of clinical trial methodologies, and familiarity with regulatory standards like SDTM/ADaM. Preferred: experience with sample size software, supporting submissions, and working in biotech or CRO environments. High-value specifics: support for clinical trials in neuroendocrine indications, across phases, with emphasis on regulatory documentation and data standards. Location: Boston-based with hybrid work; some travel expected.