Senior Biostatistician

Role: Senior Biostatistician leading statistical design, analysis, and reporting for phase I-III clinical trials in immunotherapy/cell therapy, supporting oncology and infectious disease indications. Responsibilities: design trials, develop statistical analysis plans, contribute to protocol and regulatory document writing, guide dataset development, ensure regulatory submission readiness, and mentor junior staff. Requirements: Bachelor’s or Master’s in Statistics/Biostatistics with 5+ or 7+ years of relevant industry experience; proficiency in SAS, CDISC standards, and sample size software; strong understanding of clinical research, GCP, and regulatory requirements. Preferred: experience as a lead on multiple projects, familiarity with clinical trial design innovations. High-Value: expertise in immunotherapy/biologics, early to late-phase oncology/infectious disease programs, regulatory submission processes. Work Setup: flexible onsite/remote in Southern California, with no specified travel requirements.