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 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 location.
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.
Skills Required
- PhD in Statistics or related field with 4+ years industry experience, or MS with 7+ years experience
- Strong knowledge of statistical concepts and techniques used in clinical development
- Knowledge of GCP, ICH, and CDISC regulatory/data standards
- Strong SAS programming experience
- Experience supporting clinical study design, analysis, and reporting in pharmaceutical/biotech settings
- Ability to manage competing priorities and deliver high-quality work under tight timelines
- Excellent communication and project management skills
- Collaborative teamwork and interpersonal skills demonstrating initiative
- Oncology and/or autoimmune disease clinical trial experience
- Early-phase disease experience
What We Do
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
