Senior Manager, Biostatistics

About the role

Fatetherapeutics is seeking a statistician to join the biostatistics department and provide statistical support for clinical studies within the company portfolio. In this capacity, the successful candidate will act as the study statistician, taking ownership of the statistical design, execution, analysis, and reporting for assigned studies. This role requires collaboration with cross-functional teams to ensure statistical rigor and alignment with project objectives. The position will report directly to the Executive Director, Biostatistics. The hire will contribute to the advancement of clinical programs by applying statistical best practices and scientific judgment. This is an opportunity to influence key decisions that impact data quality and study outcomes. The individual in this role will help maintain the integrity of the clinical development lifecycle from protocol design through final reporting. This position is integral to the biostatistics department's ability to deliver compliant and timely study results.

Key facts

What you'll do

• Contribute statistical and operational expertise to protocol design, sample size calculations, and endpoint selection for clinical studies.
• Create detailed statistical analysis plans, programming specifications, and mock shells to guide analysis activities.
• Execute and validate clinical trial data analyses to ensure adherence to timelines and regulatory expectations.
• Assist with study setup activities, including electronic data capture system testing and initial design considerations.
• Participate in data review processes for Data Monitoring Committees, Safety Assessment Committees, and Adjudication Committees.
• Oversee statistical deliverables produced by internal programming teams or contract research organization partners.
• Partner with clinical operations, regulatory, clinical development, quality assurance, and translational science teams to uphold statistical compliance.
• Support the development and enhancement of departmental infrastructure, standards, and analytical methodologies.
• Monitor and apply current regulatory guidance, including ICH, GCP, and CDISC standards, to all analysis activities.
• Evaluate and implement emerging statistical methodologies to improve the efficiency and robustness of clinical trial analysis.
• Lead the preparation of statistical sections in clinical study reports to ensure clarity and regulatory acceptability.
• Provide mentorship and guidance to junior biostatistics team members on study design and analysis issues.
• Liaise with external collaborators and CROs to align statistical approaches with project-specific requirements.
• Drive continuous improvement in biostatistics practices through lessons learned and cross-team knowledge sharing.

Requirements

• Hold a PhD in Statistics or a related scientific field with at least 4 years of pharmaceutical or biotech industry experience.
• Alternatively, possess an MS degree with at least 7 years of relevant experience in a pharmaceutical or biotech setting.
• Demonstrate proficiency in SAS programming for data management and statistical analysis.
• Show a deep understanding of clinical development statistical techniques and core biostatistical concepts.
• Exhibit familiarity with ICH guidelines, GCP principles, and CDISC standards and their application in clinical trials.
• Prove the ability to manage multiple concurrent projects while consistently meeting established deadlines.
• Display strong project management capabilities and effective written and verbal communication skills.
• Maintain attention to detail and accuracy in all analytical outputs and documentation.
• Demonstrate the capacity to work independently and as part of a collaborative team in a matrixed environment.
• Commit to upholding the highest standards of data integrity and regulatory compliance in all activities.

Nice to have

• Hands-on experience with oncology or autoimmune disease clinical trials.
• Experience supporting early-phase clinical trials and innovative study designs.

Practical notes

• The anticipated annual salary range for this position is $145,000.00 to $180,000.00, subject to variation based on experience, internal equity considerations, and individual qualifications.
• Compensation for this role includes an annual bonus, equity awards, and a comprehensive benefits package.
• Travel for this position is estimated at up to 10 percent, primarily for team meetings, study visits, or regulatory interactions as needed.
• Physical demands of the role include extended periods of sitting or standing and the ability to monitor screens and study activities for prolonged durations.
• All official correspondence from Fatetherapeutics regarding this role must be sent to the @fatetherapeutics.com email domain.
• Candidates should be aware that the company does not request payments or banking deposits at any stage of the hiring process.