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.