Senior Director and Head of Biostatistics at International AIDS Vaccine Initiative (IAVI)

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.

Contribute to Biostatistics resource planning, vendor budget development, and budget monitoring to ensure alignment with study and program priorities.

Foster a collaborative, quality-focused, and scientifically rigorous Biostatistics function.

Education and Work Experience:

Master’s Degree in Statistics, Biostatistics, or related discipline is required; Ph.D. is desirable.

Minimum 10 years of progressive experience in clinical Biostatistics within biotechnology, pharmaceutical, vaccine, or related life sciences settings required.

Minimum 5 years of people management, functional leadership, matrix leadership, and/or vendor oversight experience required.

Qualifications and Skills:

Demonstrated experience providing statistical leadership for drug, vaccine, biologics, or related clinical development programs required.

Advanced knowledge of clinical trial design, experimental design, power and sample size calculations, survival analysis, longitudinal data methods, and linear/generalized linear models is required.

Experience contributing to or supporting U.S. and/or EU regulatory submissions, regulatory-facing documentation, or regulatory interactions required.

Experience leading Biostatistics standards, processes, tools, templates, or SOPs strongly preferred.

Familiarity with current ICH guidance pertinent to clinical development is required.

Advanced knowledge of ICH GCP content and application, ICH E series Guidelines, Good Clinical Laboratory Practices, Quality Management Systems, and 21 CFR Part 11 are required.

Demonstrated ability to lead, prioritize, and develop a high-performing Biostatistics function in a complex, matrixed environment.

Excellent oral, written, and presentation skills are required.

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.

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