Senior Director of Biostatistics

San Francisco

Permanent

$250,000 - $310,000 USD a year

Clinical

PR/597298_1785865395

Location: San Francisco, CA Preferred | Remote Considered

Our client, a well-funded clinical-stage biotechnology company advancing next-generation autoimmune CAR-T therapies, is seeking a Director/Senior Director, Biostatistics to provide strategic and operational statistical leadership across its clinical development portfolio.

Reporting to the Head of Biometrics, this individual will serve as the lead statistical expert, partnering closely with clinical, regulatory, and executive leadership teams to drive study design, data analysis, regulatory strategy, and decision-making.

This is a highly visible role with the opportunity to make a significant impact on a cutting-edge cell therapy pipeline.

Key Responsibilities

Serve as the statistical lead across one or more clinical development programs.
Provide strategic input into protocol design, statistical methodology, analysis plans, and study execution.
Author and review key statistical documents, including SAPs and regulatory submission deliverables.
Lead 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 external 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 provide technical leadership.

Qualifications

PhD or Master's degree in Biostatistics, Statistics, or a related quantitative discipline.
10+ years of biotech and/or pharmaceutical industry experience in clinical biostatistics.
Proven experience leading statistical strategy 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 SAS; R experience preferred.
Prior experience in a clinical-stage biotech environment strongly preferred.

Preferred Background

Experience in cell therapy, CAR-T, immunology, autoimmune disease, hematology, or oncology.
Experience supporting early-phase and complex clinical development programs.
Comfortable operating in a fast-paced, highly collaborative biotech environment.
Able to balance strategic leadership with hands-on execution.

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