Senior Director – Head of Biostatistics

This is a fully remote position, open to applicants in United States, +6 more locations.

📋 Description

• Act as the Head of Biostatistics, establishing functional direction, priorities, standards, and operational methodologies for IAVI-sponsored studies and programs.

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

• Collaborate with Clinical Development and cross-functional leaders to ensure biostatistical strategies are aligned with program objectives, evidence requirements, regulatory expectations, and scientific priorities.

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

• Provide high-level statistical guidance on study design, endpoint selection, sample size assumptions, analysis methodologies, and result interpretations.

• Lead or review protocols, statistical analysis plans, study reports, CRFs, Investigator’s Brochures, randomization specifications, DMPs, grant proposals, and other trial-related documentation.

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

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

• Manage Biostatistics vendor relationships and deliverables, ensuring quality, 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 to ensure data quality, analysis readiness, and inspection-ready deliverables.

• Identify and escalate risks related to statistical quality, timelines, resources, vendor performance, or compliance.

• Lead and mentor Biostatistics colleagues through clear expectations, coaching, feedback, professional development, and workload management.

• Contribute to resource planning, vendor budget creation, and budget monitoring.

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

⛳️ Requirements

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

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

• A minimum of 5 years of experience in people management, functional leadership, matrix leadership, and/or vendor oversight is essential.

• Proven experience in providing statistical leadership for drug, vaccine, biologics, or related clinical development programs is required.

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

• Experience in contributing to or supporting U.S. and/or EU regulatory submissions, regulatory documentation, or regulatory interactions is required.

• Experience leading Biostatistics standards, processes, tools, templates, or SOPs is highly preferred.

• Familiarity with current ICH guidance relevant to clinical development is necessary.

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

• Demonstrated capability 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 adjust plans to meet the evolving needs of studies, programs, and the organization.

🏝️ Benefits

• Annual bonus

• Generous retirement savings plan

• Three health insurance plans to choose from

• Eligible overtime hours compensated in accordance with applicable law