Senior Director and Head of Biostatistics

Role Overview

The Head of Biostatistics sets the statistical direction for IAVI-sponsored research, guiding study teams from design through analysis and interpretation. This senior leader ensures that statistical approaches are scientifically sound, fit program goals, and produce reliable evidence for clinical, regulatory, and scientific use.

Key Responsibilities

• Establish Biostatistics priorities, standards, processes, and ways of working across sponsored studies and programs.
• Advise clinical development, epidemiology, clinical immunology, and selected pre-clinical teams on statistical strategy and evidence-generation needs.
• Guide study design decisions, including endpoints, sample-size assumptions, analysis methods, and interpretation of findings.
• Write or provide senior review of protocols, statistical analysis plans, clinical study reports, case report forms, randomization specifications, data management plans, Investigator’s Brochures, grant proposals, and related documents.
• Review statistical tables, listings, figures, and other study outputs, and contribute statistical expertise to publications.
• Oversee external Biostatistics providers, including deliverable quality, work scope, budgets, timelines, SOP compliance, and resolution of performance issues.
• Improve statistical tools, templates, procedures, and standards while working with Data Management, Clinical Operations, Quality Assurance, and study teams to support data quality and inspection-ready outputs.
• Lead and develop Biostatistics staff, plan workloads and resources, monitor vendor budgets, and raise risks involving quality, compliance, capacity, or timelines.

Requirements & Qualifications

• Master’s degree in Statistics, Biostatistics, or a related discipline; a Ph.D. is preferred.
• At least 10 years of progressive clinical Biostatistics experience in biotechnology, pharmaceuticals, vaccines, or a related life sciences field.
• At least 5 years of experience in people management, functional or matrix leadership, and/or vendor oversight.
• Demonstrated statistical leadership on clinical development programs involving drugs, vaccines, biologics, or related products.
• Advanced knowledge of clinical and experimental trial design, power and sample-size calculations, survival analysis, longitudinal methods, and linear and generalized linear models.
• Experience supporting U.S. and/or EU regulatory submissions, regulatory documentation, or interactions with regulators.
• Working knowledge of current ICH guidance relevant to clinical development, including ICH E series guidance, as well as ICH GCP, Good Clinical Laboratory Practices, quality management systems, and 21 CFR Part 11.
• Experience establishing or improving Biostatistics standards, procedures, tools, templates, or SOPs is strongly preferred.
• Ability to build and guide an effective function in a complex, matrixed setting; balance resources and competing priorities; and adjust plans as study and program needs change.
• Strong written, verbal, and presentation skills, with the ability to lead cross-functional work and communicate statistical considerations clearly.