Director, Biostatistics

Role: Lead biostatistician overseeing statistical strategy and analysis for oncology clinical trials at Summit Therapeutics, primarily in Phase 3 studies for NSCLC and colorectal cancer. Responsibilities include designing studies, developing statistical analysis and development plans, reviewing clinical data, authoring regulatory documentation, and ensuring data quality and compliance. The position involves collaboration with clinical teams, CROs, and regulatory bodies, including interactions with FDA. Requirements: PhD (or MS with extensive experience) in biostatistics or related field, 8+ (PhD) or 11+ (MS) years of industry experience supporting oncology trials, with expertise in clinical trial design, statistical methodologies, and regulatory submissions (NDA, BLA). Skills include proficiency in SAS, R, EAST, and familiarity with CDISC standards, GCP, ICH, and FDA regulations. The role requires strong communication skills and experience in supporting Phase II/III oncology studies, with a focus on lung and colorectal cancers. Work setup: not specified, likely in a collaborative, regulated environment with cross-functional interactions.