Senior Director – Head of Biostatistics

This is a fully remote position, open to applicants in South Africa, +5 more countries.

📋 Description

• Establish the functional direction, priorities, standards, and operational methods for Biostatistics within IAVI-sponsored studies and programs.

• Deliver strategic statistical leadership to teams in clinical, epidemiology, clinical immunology, and selected pre-clinical areas.

• Collaborate with Clinical Development and cross-functional leaders to ensure biostatistical strategies align with program goals, evidence-generation requirements, regulatory standards, and scientific priorities.

• Act as a senior subject matter expert on Biostatistics processes, standards, tools, templates, and SOPs.

• Provide senior statistical insights into study design, endpoint selection, sample size assumptions, analysis methodologies, and result interpretations.

• Lead or conduct senior reviews of protocols, statistical analysis plans, study reports, CRFs, Investigator’s Brochures, randomization specifications, DMPs, grant proposals, and other trial documentation.

• Conduct senior reviews of tables, listings, figures, and statistical outputs for IAVI studies.

• Assist with scientific publications by providing statistical input, interpretation, review, and coordination.

• Oversee Biostatistics vendor relationships and deliverables, including quality expectations, adherence to SOPs, scope of work, budgets, timelines, and issue escalation.

• Promote continuous improvement in Biostatistics processes, templates, tools, and standards.

• Collaborate with Data Management, Clinical Operations, Quality Assurance, and study teams on data quality, analysis readiness, and inspection-ready deliverables.

• Identify and elevate risks associated with statistical quality, timelines, resources, vendor performance, or compliance.

• Lead and develop Biostatistics colleagues by setting expectations, providing coaching, feedback, professional growth opportunities, workload planning, and prioritization.

• Participate in resource planning, vendor budget development, and budget monitoring.

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

⛳️ Requirements

• A Master’s Degree in Statistics, Biostatistics, or a related field is mandatory.

• At least 10 years of progressive experience in clinical Biostatistics within biotechnology, pharmaceutical, vaccine, or related life sciences environments.

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

• Proven experience providing statistical leadership for drug, vaccine, biologics, or similar clinical development programs.

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

• Experience in contributing to or supporting U.S. and/or EU regulatory submissions, regulatory-facing documentation, or interactions with regulatory bodies.

• Familiarity with current ICH guidance relevant to clinical development.

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

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

• Exceptional oral, written, and presentation skills.

• Proven capability to assess resource needs, manage competing priorities, and align Biostatistics deliverables with study and program timelines.

• Demonstrated ability to lead cross-functional teams, manage competing priorities, and adjust plans to accommodate changing study, program, and organizational requirements.

🏝️ Benefits

• Annual bonus.

• Generous retirement savings plan.

• Choice of three health insurance plans.

• Eligible overtime hours compensated in accordance with applicable law.