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.