Director, Biostatistical Programming

Role: Director of Biostatistical Programming responsible for developing clinical study deliverables, overseeing vendor programming activities, and supporting internal data analysis requests. Responsibilities include managing vendor quality, reviewing clinical trial data, assisting in regulatory submissions (e.g., DSUR/IBs), and establishing programming and QC processes aligned with CDISC standards. Requirements: Bachelor's degree in statistics, mathematics, or related field with 15+ years in pharma, or a master's with 12+ years; extensive SAS programming expertise, deep understanding of CDISC standards, and experience managing CRO relationships; oncology therapeutic area experience essential. High-Value: Oncology, radiopharmaceutical therapies, clinical trial data management, regulatory document support, FDA/ICH guidelines, GxP compliance, and statistical programming infrastructure. Collaboration involves cross-functional teams and external vendors. Work setup: Based in San Diego, with approximately 10% travel and flexible work environment.