VP, Head of Biometrics

Career Opportunities with TScan Therapeutics A great place to work.   Careers At TScan Therapeutics Current job opportunities are posted here as they become available.     Back To Openings     VP, Head of Biometrics Department: 30 - Clinical Location: Waltham, MA START YOUR APPLICATION Position Summary: TScan is seeking an accomplished and strategic Vice President, Biostatistics to lead all biometric activities across the company's clinical development portfolio, including multiple ongoing and planned studies supporting the advancement of TCR-T cell therapies for patients with cancer. This executive leader will be responsible for defining and executing the statistical and biometrics strategy, ensuring scientific rigor, regulatory compliance, and operational excellence from first-in-human to late-stage development, including regulatory submission and commercialization. As a key member of the Senior Leadership Team, the VP, Biostatistics will partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Sciences, Translational Medicine and Executive Leadership to drive successful development and registration strategies. The individual will serve as the primary statistical representative to regulatory authorities and external stakeholders, and will play a critical role in shaping the future of TScan's clinical development organization. Responsibilities: Strategic Leadership Establish and lead the biostatistics strategy across TScan's clinical development portfolio, from Phase 1 to registrational and post-registration studies. Provide statistical leadership and strategic guidance to executive management on development plans, clinical study design, endpoint selection, estimands, and data interpretation. Contribute to portfolio strategy, lifecycle management planning, and business development evaluations. Serve as a trusted advisor to senior leadership on benefit-risk assessments and key development decisions. Clinical Development & Regulatory Strategy Lead statistical design and analysis planning for all clinical studies. Oversee development of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), integrated summaries, and regulatory submission documents. Drive statistical strategy for complex cell therapy clinical programs, including durability analyses, long-term follow-up, safety monitoring, and innovative endpoint development. Represent Biostatistics in interactions with FDA, EMA, and other global regulatory agencies. Provide leadership for regulatory submissions, including BLA and international marketing applications. Ensure all statistical deliverables are scientifically sound and aligned with global regulatory expectations. Functional Leadership Build and lead a high-performing biostatistics organization. Oversee external CROs, statistical programming partners, and consultants to ensure quality, efficiency, and compliance. Establish and continuously improve departmental processes, standards, and quality systems. Foster a culture of scientific excellence, innovation, collaboration, and accountability. Cross-Functional Collaboration Partner with Clinical Development to optimize study designs and interpret emerging clinical data. Collaborate closely with Data Management and Statistical Programming teams to ensure high-quality and timely analyses. Support Medical Affairs, Publications, and Investor Relations through statistical interpretation and communication of clinical results. Present statistical findings and strategic recommendations to senior leadership, Board members, and external stakeholders. Requirements: Education PhD in Biostatistics, Statistics, or a related quantitative discipline required. Experience Minimum of 15 years of biostatistics experience in biotechnology, pharmaceutical,...