Senior Manager, Biostatistics
Fate Therapeutics Inc.
August 08, 2026
On-site
San Diego, CA
Clinical Research and Development
Responsibilities:
- Provide statistical and operational input in protocol design, outcome measures, and sample size justification.
- Develop statistical analysis plans, mock shells, programming specifications, and other key trial documents.
- Perform and validate statistical analyses of clinical trial data to ensure timely and accurate reporting.
- Support study setup activities including EDC design and testing.
- Support data review activities (e.g., Safety Assessment Committees, Data Monitoring Committees, Adjudication Committees).
- Review and provide feedback on statistical deliverables from CROs or internal programming teams.
- Collaborate with cross-functional teams (clinical development, clinical operations, data management, regulatory, translational science, quality assurance) to ensure statistical integrity and compliance.
- Assist in development and implementation of departmental standards and infrastructure initiatives.
- Stay current with relevant statistical methodology and regulatory guidance and apply as appropriate.
Qualifications:
- PhD in Statistics (or related field) with 4+ years’ experience in pharma/biotech, or MS with 7+ years’ experience.
- Strong knowledge of statistical concepts and techniques used in clinical development.
- Knowledge of GCP, ICH, CDISC, and other pertinent regulatory guidance.
- Strong SAS programming experience.
- Ability to manage competing priorities and deliver quality work under tight timelines.
- Excellent communication and project management skills.
- Oncology and/or autoimmune disease clinical trial experience strongly preferred; early-phase experience a plus.
- Collaborative teamwork and interpersonal skills.
Compensation:
- Annual bonus, equity, and generous benefits package; anticipated salary range: $145,000–$180,000.
Working Conditions:
- Travel up to 10%.
Location/Reporting:
- Full-time; reports to Executive Director, Biostatistics; corporate headquarters in San Diego, CA.
- Provide statistical and operational input in protocol design, outcome measures, and sample size justification.
- Develop statistical analysis plans, mock shells, programming specifications, and other key trial documents.
- Perform and validate statistical analyses of clinical trial data to ensure timely and accurate reporting.
- Support study setup activities including EDC design and testing.
- Support data review activities (e.g., Safety Assessment Committees, Data Monitoring Committees, Adjudication Committees).
- Review and provide feedback on statistical deliverables from CROs or internal programming teams.
- Collaborate with cross-functional teams (clinical development, clinical operations, data management, regulatory, translational science, quality assurance) to ensure statistical integrity and compliance.
- Assist in development and implementation of departmental standards and infrastructure initiatives.
- Stay current with relevant statistical methodology and regulatory guidance and apply as appropriate.
Qualifications:
- PhD in Statistics (or related field) with 4+ years’ experience in pharma/biotech, or MS with 7+ years’ experience.
- Strong knowledge of statistical concepts and techniques used in clinical development.
- Knowledge of GCP, ICH, CDISC, and other pertinent regulatory guidance.
- Strong SAS programming experience.
- Ability to manage competing priorities and deliver quality work under tight timelines.
- Excellent communication and project management skills.
- Oncology and/or autoimmune disease clinical trial experience strongly preferred; early-phase experience a plus.
- Collaborative teamwork and interpersonal skills.
Compensation:
- Annual bonus, equity, and generous benefits package; anticipated salary range: $145,000–$180,000.
Working Conditions:
- Travel up to 10%.
Location/Reporting:
- Full-time; reports to Executive Director, Biostatistics; corporate headquarters in San Diego, CA.