Senior Manager, Biostatistics

Fate Therapeutics Inc.; San Diego (CA); On-site; USD 145,000 - 180,000; Full time

Job summary

Fate Therapeutics, Inc. in San Diego, CA is seeking a highly skilled statistician to join the biostatistics team as study statistician on assigned clinical studies.

This full-time role will contribute to design, analysis, and reporting of trial data. You will design and analyze statistical deliverables, support EDC and study setup, and collaborate with cross-functional teams to ensure regulatory compliance and high-quality results.

Qualifications

• PhD or MS with required years of experience in pharma/biotech
• Strong knowledge of statistical methods used in clinical development
• Excellent communication and project management skills

Responsibilities

• Provide sound statistical input in protocol design and sample size justification.
• Develop statistical analysis plans and key trial documents.
• Perform and validate analyses of clinical trial data for timely reporting.
• Support study setup activities including EDC design and testing.
• Review statistical deliverables from CROs or internal teams.
• Collaborate with cross-functional teams to ensure statistical integrity and compliance.
• Assist in development of departmental standards and infrastructure initiatives.
• Stay current with regulatory guidance and relevant statistical methods.

Skills

Statistical concepts

Communication skills

Project management

Collaborative teamwork

Education

PhD in Statistics or related field

MS in Statistics or related field

Tools

SAS programming

Job description

Fate Therapeutics is seeking a highly skilled and motivated statistician to join our growing biostatistics team to support clinical studies across Fate’s expanding portfolio. This individual will serve as study statistician on assigned clinical studies, provide statistical support on clinical study design, setup, execution, analysis, and reporting, and contribute as a key member of a cross‑functional team. This position requires solid technical and communication skills, and the ability to work independently with moderate guidance. This is a full‑time position reporting to the Executive Director, Biostatistics and is located at our corporate headquarters in San Diego, CA.

Responsibilities

• Provide sound 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, including and not limited to 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 such as clinical development, clinical operations, data management, regulatory, translational science, and 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 scientific field with 4+ years of relevant experience in the pharmaceutical/biotech industry, or MS with 7+ years of 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.
• Demonstrated ability to manage competing priorities and deliver high‑quality work under tight timelines.
• Excellent communication and project management skills.
• Oncology and/or autoimmune disease clinical trial experience strongly preferred. Early‑phase disease experience a plus.
• Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation.

Working Conditions & Physical Requirements

• Travel may be required (up to 10%).
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $145,000 - $180,000.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.