Senior Director – Head of Biostatistics

• Set functional direction, priorities, standards, and operating approaches for Biostatistics across IAVI-sponsored studies and programs
• Provide strategic statistical leadership to clinical, epidemiology, clinical immunology, and select pre-clinical teams
• Partner with Clinical Development and cross-functional leaders to align biostatistical strategies with program objectives, evidence-generation needs, regulatory expectations, and scientific priorities
• Serve as a senior subject matter expert for Biostatistics processes, standards, tools, templates, and SOPs
• Provide senior statistical input into study design, endpoint selection, sample size assumptions, analysis methodology, and interpretation of results
• Lead or provide senior review of protocols, statistical analysis plans, study reports, CRFs, Investigator’s Brochures, randomization specifications, DMPs, grant proposals, and other trial documentation
• Perform senior review of tables, listings, figures, and statistical outputs for IAVI studies
• Support scientific publications with statistical input, interpretation, review, and coordination
• Oversee Biostatistics vendor relationships and deliverables, including quality expectations, SOP adherence, scope of work, budgets, timelines, and issue escalation
• Drive continuous improvement of Biostatistics processes, templates, tools, and standards
• Partner with Data Management, Clinical Operations, Quality Assurance, and study teams on data quality, analysis readiness, and inspection-ready deliverables
• Identify and escalate risks related to statistical quality, timelines, resources, vendor performance, or compliance
• Lead and develop Biostatistics colleagues through expectations, coaching, feedback, professional growth, workload planning, and prioritization
• Contribute to resource planning, vendor budget development, and budget monitoring
• Foster a collaborative, quality-focused, and scientifically rigorous Biostatistics function

• Master’s Degree in Statistics, Biostatistics, or related discipline is required
• Minimum 10 years of progressive experience in clinical Biostatistics within biotechnology, pharmaceutical, vaccine, or related life sciences settings
• Minimum 5 years of people management, functional leadership, matrix leadership, and/or vendor oversight experience
• Demonstrated experience providing statistical leadership for drug, vaccine, biologics, or related clinical development programs
• Advanced knowledge of clinical trial design, experimental design, power and sample size calculations, survival analysis, longitudinal data methods, and linear/generalized linear models
• Experience contributing to or supporting U.S. and/or EU regulatory submissions, regulatory-facing documentation, or regulatory interactions
• Familiarity with current ICH guidance pertinent to clinical development
• Advanced knowledge of ICH GCP content and application, ICH E series Guidelines, Good Clinical Laboratory Practices, Quality Management Systems, and 21 CFR Part 11
• Demonstrated ability to lead, prioritize, and develop a high-performing Biostatistics function in a complex, matrixed environment
• Excellent oral, written, and presentation skills
• Proven ability to assess resource needs, manage competing priorities, and align Biostatistics deliverables with study and program timelines
• Proven ability to lead cross-functional teams, manage competing priorities, and adapt plans to meet evolving study, program, and organizational needs

• Annual bonus
• Generous retirement savings plan
• Choice of three health insurance plans
• Eligible overtime hours compensated in accordance with applicable law