Senior Biostatistics Lead - Clinical Trials Strategy

Fatetherapeutics; San Diego (CA); On-site; USD 145,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Equity

Generous benefits package

Job summary

Fate Therapeutics, Inc. seeks a highly skilled statistician to join its biostatistics team in San Diego. The role focuses on supporting clinical studies, designing trials, and reporting analyses as a key study statistician within cross‑functional teams.

The candidate will contribute to protocol design, SAP development, and statistical deliverables, with strong SAS programming and regulatory familiarity. A PhD or MS with extensive biotech experience is preferred.

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.

Responsibilities

• Provide sound statistical 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 Safety Assessment Committees, Data Monitoring Committees, and 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.

Skills

SAS programming

Statistical methods

Regulatory guidance

Communication skills

Project management

Oncology trials

Education

PhD in Statistics or related field

MS in Statistics or related field

Tools

SAS

Job description

Fate Therapeutics, Inc. seeks a highly skilled statistician to join its biostatistics team in San Diego. The role focuses on supporting clinical studies, designing trials, and reporting analyses as a key study statistician within cross‑functional teams.

The candidate will contribute to protocol design, SAP development, and statistical deliverables, with strong SAS programming and regulatory familiarity. A PhD or MS with extensive biotech experience is preferred.