Senior Director – Head of Biostatistics

🔥 1 minute ago

🌐 United States, South Africa, +4 more countries – Remote

🇺🇸 United States – Remote 🇿🇦 South Africa – Remote 🇰🇪 Kenya – Remote 🇳🇱 Netherlands – Remote 🇮🇳 India – Remote 🇬🇧 United Kingdom – Remote

🗽 New York – Remote

🗽 New York – Remote

💵 $210k - $235k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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IAVI

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1996

🧬 Biotechnology

🏥 Healthcare

🤝 Non-profit

Biotechnology • Healthcare • Non-profit

IAVI is a global nonprofit biomedical research organization that develops vaccines and therapeutic antibodies for HIV, tuberculosis, and emerging infectious diseases. It pursues end-to-end product development—discovery, epidemiology, clinical development, product development, and global access—working through a network of academic, biotech, pharma, and public health partners. IAVI conducts preclinical and clinical trials, advances vaccine candidates (including rVSV-based vaccines for Lassa, Marburg, Sudan, and Bundibugyo viruses), supports broadly neutralizing antibody research for HIV, and engages in policy, advocacy, and community partnerships to ensure affordable, globally accessible public health solutions.

📋 Description

• Serve as the Head of Biostatistics, setting functional direction, priorities, standards, and operating approaches across IAVI-sponsored studies and programs • Provide strategic statistical leadership to clinical, epidemiology, clinical immunology, and select pre-clinical teams • Partner with Clinical Development and cross-functional leaders to align biostatistical strategies with program objectives, evidence needs, regulatory expectations, and scientific priorities • Serve as a senior subject matter expert for Biostatistics processes, standards, tools, templates, and SOPs • Provide senior statistical input into study design, endpoint selection, sample size assumptions, analysis methodology, and interpretation of results • Lead or review protocols, statistical analysis plans, study reports, CRFs, Investigator’s Brochures, randomization specifications, DMPs, grant proposals, and other trial documentation • Perform senior review of tables, listings, figures, and statistical outputs for IAVI studies • Support scientific publications through statistical input, interpretation, review, and coordination • Oversee Biostatistics vendor relationships and deliverables, including quality, SOP adherence, scope of work, budgets, timelines, and issue escalation • Drive continuous improvement of Biostatistics processes, templates, tools, and standards • Partner with Data Management, Clinical Operations, Quality Assurance, and study teams on data quality, analysis readiness, and inspection-ready deliverables • Identify and escalate risks involving statistical quality, timelines, resources, vendor performance, or compliance • Lead and develop Biostatistics colleagues through expectations, coaching, feedback, professional growth, and workload planning • Contribute to resource planning, vendor budget development, and budget monitoring • Foster a collaborative, quality-focused, scientifically rigorous Biostatistics function

🎯 Requirements

• 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 • 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

🏖️ Benefits

• Annual bonus • Generous retirement savings plan • Three health insurance plans to choose from • Eligible overtime hours compensated in accordance with applicable law

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