Associate Director, Biostatistics & AI

Role: Associate Director, Biostatistics & AI, leading high-quality statistical analyses and integrating AI/ML tools into biometrics workflows within biopharma development. Responsibilities: apply statistical methods across clinical trial phases (II-IV), support regulatory submissions (NDA, BLA, MAA), design and implement AI/ML interfaces connecting biometrics platforms (SAS, R, Python) with enterprise data systems, and establish GxP-compliant AI governance and MLOps pipelines. Collaborate with Clinical, Regulatory, Medical, and PV teams; manage CRO statisticians and programmers. Requirements: PhD or Master’s in Biostatistics, Statistics, Data Science, or related; 5+ years (PhD) or 7+ years (Master’s) biostatistics experience; proficiency in SAS/R, familiarity with Python; experience with clinical datasets, CDISC standards, and regulatory processes. Alternatively, 3+ years AI/ML engineering experience with clinical/life sciences data exposure, Python expertise, and some biostatistics familiarity. High-Value: clinical development (Phases II-IV), regulatory submissions, GxP environment, AI/ML integration, cross-functional collaboration. Work setup: remote U.S.-based with quarterly in-person visits to San Francisco; no specified travel percentage.