Senior Director, Biostatistics

About the role

The Senior Director of Biostatistics will lead and oversee all statistical activities supporting Phase 2 and Phase 3 clinical trials and pivotal nonhuman primate (NHP) studies in cutting-edge vaccine development programs. This role will provide statistical leadership across a range of functional areas, including human and clinical immunology assay development, nonhuman primate (NHP) nonclinical studies, and Chemistry, Manufacturing & Controls (CMC).

Responsibilities

• Provide strategic input to senior leadership on statistical implications of development strategies across functional areas
• Lead statistical strategy for Phase 2/3 clinical trials, including study design, SAP development, and data interpretation
• Oversee statistical deliverables from CROs and external partners, including interim analyses, study reports, and regulatory submissions, ensuring quality and adherence to timelines
• Partner with clinical and translational teams to support immunobridging models and innovative approaches to vaccine licensure
• Guide statistical design and analysis of pivotal nonclinical studies, ensuring alignment with clinical objectives
• Provide statistical expertise in process development, analytical validation, and stability/shelf-life modeling
• Manage relationships with external vendors, key opinion leaders, and regulatory agencies to ensure effective stakeholder engagement and alignment
• Mentor and develop internal statisticians and other team members; manage external vendors and resources

Requirements

• Minimum of a graduate degree in Biostatistics, Statistics, or a related field; doctoral degree strongly preferred
• 14+ years of biostatistics experience in pharma/biotech, with substantial leadership in late-phase clinical development
• Expertise in clinical trial design, regulatory submissions, and statistical modeling in vaccines or infectious diseases
• Experience with immunobridging, logistical regression methods, and Bayesian or frequentist modeling
• Working knowledge of CMC statistics, assay validation, and nonclinical study design
• Proficiency in statistical programming (e.g., SAS, R, Python); experience with CDISC standards is a plus
• Proven leadership, communication, and cross-functional collaboration skills