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.