Associate Director, Statistical Programming

Role: Senior Statistical Programmer supporting exploratory-stage oncology clinical trials, with a focus on late-phase programs for RAS-mutant cancers. Responsibilities: provide hands-on SAS programming support, oversee programming activities for internal deliverables and regulatory submissions, ensure compliance with CDISC standards, and lead one or more early or late phase studies. Collaborate with cross-functional teams to meet timelines, manage vendors, and prepare datasets, tables, listings, figures, and key documents like SDTM, ADaM, and analysis plans. Participate in audits, review documentation, and support regulatory filings. Requirements: 14+ years of SAS programming experience in early or late-phase oncology trials, BS/BA degree or equivalent, leadership in managing programming vendors, proficiency in dataset analysis and regulatory documentation. Preferred skills include leadership qualities, experience in small/medium biotech environments, and process development expertise. High-value: Oncology (RAS pathway, specific mutations including G12C, G12D, G12V), exploratory/early and late-phase clinical trials, regulatory compliance (FDA 21 CFR Part 11, GxP), and expertise in SDTM/ADaM standards. Work setup involves onsite presence in Redwood City, CA, with a base salary range of $186,000–$233,000 USD.