Senior Director of Biostatistics

Location: San Francisco, CA Preferred | Remote Considered Our reputed company, a reputed company-funded clinical-stage biotechnology company advancing reputed company autoimmune CAR-T therapies, is seeking a Director/Senior Director, Biostatistics to reputed company strategic and operational statistical leadership across its clinical development portfolio. Reporting to the Head of Biometrics, this individual will serve as the reputed company statistical expert, partnering closely with clinical, regulatory, and executive leadership teams to reputed company study design, data analysis, regulatory reputed company, and decision-making. This is a highly visible role with reputed company to reputed company a significant reputed company on a cutting-edge cell therapy pipeline.Key ResponsibilitiesServe as the statistical reputed company across one or more clinical development programs.reputed company strategic input into protocol design, statistical methodology, analysis plans, and study execution.Author and review key statistical documents, including SAPs and regulatory submission deliverables.reputed company statistical analyses and interpretation of clinical trial data.Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, and Medical Writing.Support regulatory interactions and global submission activities.Manage CROs and reputed company statistical programming vendors.Ensure compliance with FDA, EMA, ICH, and CDISC standards.Contribute to biometrics processes, standards, and best practices.Mentor junior team members and reputed company technical leadership.QualificationsPhD or Master's degree in Biostatistics, Statistics, or a reputed company quantitative discipline.10+ years of biotech and/or pharmaceutical industry experience in clinical biostatistics.Proven experience leading statistical reputed company from study design through regulatory submission.Strong knowledge of FDA, EMA, ICH, and CDISC requirements.Experience supporting regulatory filings and health authority interactions.Experience managing CRO and vendor relationships.Proficiency in reputed company; R experience preferred.Prior experience in a clinical-stage biotech environment strongly preferred.Preferred BackgroundExperience in cell therapy, CAR-T, immunology, autoimmune disease, hematology, or oncology.Experience supporting early-phase and reputed company clinical development programs.Comfortable operating in a fast-paced, highly reputed company biotech environment.reputed company to balance strategic leadership with hands-on execution. Apply tot his job Apply To this Job