Principal Statistical Analyst

Role: Senior Statistical Programmer with extensive experience supporting exploratory and clinical oncology trials, overseeing programming activities for early or late-phase programs in a biotech setting. Responsibilities: provide hands-on SAS programming, lead vendor and contractor management, ensure regulatory compliance (FDA 21 CFR Part 11, GxP), and support regulatory submissions and internal deliverables (datasets, TLFs, SAPs, CRFs). Participate in audits, oversee documentation, and contribute to process development. Requirements: 14+ years in statistical programming for oncology trials, BS/BA or relevant qualification, proven leadership in managing programming teams and vendors, expert SAS skills, ability to multi-task, prioritize and collaborate effectively. Preferred: demonstrated leadership, teamwork, experience in small/mid-sized biotech, and process development for programming functions. HighValue: oncology (RAS pathway, G12C/D/V, multi-asset pipeline), early and late-phase clinical development, regulatory submissions, GxP compliance, cross-functional collaboration. WorkSetup: primarily onsite in Redwood City, CA, with competitive salary range $186K-$233K, including benefits and equity.