Hiring: Senior Biostatistics Director Company: Exelixis Location: Alameda, CA Job Posted Time: 2026-09-16 12:46:27 Employment Type: Contract Target Skills & Keywords : Project Management, Segment About the job Experience: •Equivalent combination of education and experience. •Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry. •Preferably led a phase III clinical trial. •In-depth knowledge of CDISC standards. •Management and statistical analysis of data obtained from Phase I – IV clinical studies in support of US NDAs. Required Skills: •Interface directly with department head to develop and implement department standards and practices. •Direct the statistical design, conduct, and analysis of clinical trials in all phases. •Review protocols and case report forms for soundness of trial design. •Review and or author statistical analysis plans for all phases of a trial. •Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications. •Direct the development, validation and summary of integrated safety and efficacy summaries. •Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements. •Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development. Qualifications: •May require certification in assigned area. Compensation: •$216,500 - $307,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!