Associate Director, Statistical Programming

Role: Senior Statistical Programmer supporting oncology clinical trials, primarily in exploratory and late-phase development. Responsibilities: oversee programming activities for multiple studies, ensure regulatory compliance (FDA 21 CFR Part 11, GxP), provide technical SAS support, manage vendor collaborations, prepare datasets and documentation (SDTM, ADaM, Analysis Plans, CRFs), and participate in audits and internal reviews. Requirements: 14+ years of statistical programming experience in oncology, BS/BA relevant degree, strong SAS skills for production and validation, experience leading programming vendors and cross-functional teams. Preferred: leadership and teamwork skills, experience in biotech/pharma environments, process development for programming standards. High-Value: oncology, early or late-phase trials, regulatory submissions, GxP standards, experience with SDTM/ADaM, experience managing external vendors. Work Setup: not specified; likely hybrid/onsite based on location at Redwood City, CA, with salary range $186,000–$233,000 USD.