Senior Director and Head of Biostatistics

Position Description

Job Title: Senior Director and Head of Biostatistics
Location: Cape Town, South Africa; Remote-South Africa considered; United States- Remote, Nairobi, Kenya; Kenya-Remote considered; Amsterdam, Netherlands, United Kingdom-Remote
Reports to: Head of Clinical Development

Join IAVI as Senior Director and Head of Biostatistics and play a critical role in advancing our global product development portfolio. You’ll lead the biostatistics function, provide expert guidance across clinical and research programs, and ensure rigorous statistical approaches inform study design, data analysis, immunological assessments, and key development decisions.

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.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long-term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI is an equal opportunity employer. It is IAVI’s policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.

We recognize that a variety of backgrounds and perspectives enriches our work and strengthens our ability to achieve our mission. IAVI is committed to recruiting, developing, and retaining individuals through a merit-based approach. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific non-profit organization focused on global health.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.

Compensation and Benefits Information for US-Based Candidates:

The annualized salary range is $210,000-235,000. Eligible overtime hours will be compensated in accordance with applicable law. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, a generous retirement savings plan, three health insurance plans to choose from, and other benefits.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.