Senior Director and Head of Biostatistics
Job Description
The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.
Senior Director and Head of Biostatistics
Key Responsibilities
Strategic Biostatistics leadership
- Serve as the Head of Biostatistics, setting 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 in support of IAVI-sponsored studies and programs.
- Partner with Clinical Development and cross-functional leaders to ensure biostatistical strategies support 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.
Study and program-level statistical leadership
- 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 key biostatistical trial documentation.
- Perform senior review of all tables, listings, figures, and statistical outputs for IAVI studies.
- Support scientific publications by providing statistical input, interpretation, review and coordination, as needed.
Functional operations, quality, and vendor oversight
- Oversee Biostatistics vendor relationships and deliverables, including quality expectations, adherence to SOPs, scope of work input, budget review, timelines, and issue escalation.
- Drive continuous improvement of 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 related to statistical quality, timelines, resources, vendor performance, or compliance.
People and resource leadership
- Lead and develop Biostatistics colleagues by setting clear expectations, providing coaching and feedback, supporting professional growth, and ensuring effective workload planning and prioritization.
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