Senior Director and Head of Biostatistics

IAVI•Amsterdam,

3d•$210,000 - $235,000•Remote

About The Position

IAVI is seeking a Senior Director and Head of Biostatistics to lead its Biostatistics function and provide expert statistical guidance across global clinical and research programs. The role sets functional direction, priorities, standards, and operating approaches across IAVI-sponsored studies and programs, and partners with Clinical Development and cross-functional leaders to align statistical strategies with program objectives, evidence needs, regulatory expectations, and scientific priorities. The position provides senior statistical leadership throughout study and program development, including study design, endpoint selection, sample size assumptions, analysis methods, and interpretation of results. It reviews key trial documents and statistical outputs, supports scientific publications, oversees external Biostatistics vendors, and advances quality, compliance, consistency, and operational efficiency. The role also leads and develops Biostatistics colleagues, supports resource and budget planning, and fosters a collaborative, scientifically rigorous function. IAVI is a nonprofit scientific research organization working to address urgent global health challenges, including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. The role may be based remotely in the US or South Africa, or in New York, Cape Town, Nairobi, Amsterdam, or the United Kingdom; remote work from Kenya is also considered.

Requirements

Master’s degree in Statistics, Biostatistics, or a related discipline.
At least 10 years of progressive clinical Biostatistics experience in biotechnology, pharmaceutical, vaccine, or related life sciences settings.
At least 5 years of people management, functional leadership, matrix leadership, and/or vendor oversight experience.
Demonstrated 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.
Ability to lead, prioritize, and develop a high-performing Biostatistics function in a complex, matrixed environment.
Excellent oral, written, and presentation skills.
Ability to assess resource needs, manage competing priorities, and align Biostatistics deliverables with study and program timelines.
Ability to lead cross-functional teams and adapt plans to evolving study, program, and organizational needs.

Nice To Haves

Ph.D. in Statistics, Biostatistics, or a related discipline.
Experience leading Biostatistics standards, processes, tools, templates, or SOPs.

Responsibilities

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 selected 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 on Biostatistics processes, standards, tools, templates, and SOPs.
Provide senior statistical input on 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.
Provide statistical input, interpretation, review, and coordination for scientific publications as needed.
Oversee Biostatistics vendor relationships and deliverables, including quality expectations, SOP adherence, scope-of-work input, budget review, timelines, and issue escalation.
Improve Biostatistics processes, templates, tools, and standards to support quality, consistency, compliance, and efficiency.
Partner with Data Management, Clinical Operations, Quality Assurance, and study teams on data quality, analysis readiness, and inspection-ready statistical deliverables.
Identify and escalate risks related to statistical quality, timelines, resources, vendor performance, or compliance.
Lead and develop Biostatistics colleagues through clear expectations, coaching, feedback, professional growth support, and workload planning and prioritization.
Contribute to Biostatistics resource planning, vendor budget development, and budget monitoring.
Foster a collaborative, quality-focused, and scientifically rigorous Biostatistics function.