Principal Statistical Analyst

Role: Senior Statistical Programmer supporting exploratory oncology clinical trials, with a focus on early and late phase studies, regulatory submissions, and data standards. Responsibilities: provide hands-on programming support using SAS, oversee programming vendors, ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and contribute to deliverables such as analysis datasets, tables, listings, figures, and regulatory documentation. Lead and coordinate programming activities for clinical programs, support audits, and manage timelines. Qualifications: 14+ years of SAS programming experience in oncology trials, BS/BA degree or equivalent, demonstrated leadership in managing programming vendors and delivering high-quality analysis datasets. Preferred: strong leadership and teamwork skills, experience in small/mid-sized biotech/pharma environments, and process development for Statistical Programming. High-Value: oncology, exploratory/early or late phase trials, regulatory submissions, adherence to CDISC standards, and cross-functional collaboration. WorkSetup: based in Redwood City, CA, with a salary range of $186,000–$233,000 USD.