Senior Director and Head of Biostatistics

IAVI•Amsterdam,

5d•$210,000 - $235,000

About The Position

IAVI is seeking a Senior Director and Head of Biostatistics to lead the Biostatistics function and provide expert statistical guidance across clinical and research programs. The role sets functional direction, priorities, standards, and operating approaches for IAVI-sponsored studies and programs, and partners with Clinical Development and cross-functional leaders to ensure statistical strategies support program objectives, evidence generation, regulatory expectations, and scientific priorities. The position provides senior statistical leadership throughout study design, execution, analysis, and interpretation. It oversees Biostatistics processes and standards, vendor relationships and deliverables, quality and compliance, and continuous improvement. It also leads and develops Biostatistics colleagues, supports resource and budget planning, and promotes a collaborative, quality-focused, scientifically rigorous function. The role may be based in Cape Town, South Africa; remote within South Africa; the United States (remote); Nairobi, Kenya; remote within Kenya; Amsterdam, Netherlands; or the United Kingdom (remote). It reports to the Head of Clinical Development.

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 Biostatistics functional direction, priorities, standards, and operating approaches 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 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 on study design, endpoint selection, sample-size assumptions, analysis methodology, and interpretation of results.
Lead or conduct senior review of protocols, statistical analysis plans, study reports, CRFs, Investigator’s Brochures, randomization specifications, DMPs, grant proposals, and other biostatistical trial documentation.
Conduct 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 to support data quality, analysis readiness, and inspection-ready statistical deliverables.
Identify and escalate risks involving statistical quality, timelines, resources, vendor performance, or compliance.
Lead and develop Biostatistics colleagues through clear expectations, coaching, feedback, professional-growth support, and effective 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.