Senior Manager, Biostatistics

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.

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

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.

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About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit [www.fatetherapeutics.com](http://www.fatetherapeutics.com/).