This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director and Head of Biostatistics based in the United States. Lead the biostatistics function within a global scientific research environment dedicated to advancing innovative solutions for urgent public health challenges. As Senior Director and Head of Biostatistics, you will shape statistical strategy across clinical development, epidemiology, immunology, and selected preclinical programs. You will provide scientific leadership on study design, statistical methodologies, data interpretation, and regulatory documentation to support critical product development decisions. Working closely with cross-functional teams and external partners, you will ensure rigorous scientific standards, reliable analyses, and high-quality clinical evidence. You will also oversee vendor relationships, strengthen operational processes, and develop a high-performing biostatistics team. This is an opportunity to combine strategic leadership, technical expertise, and global collaboration to help advance vaccines, antibodies, and other biomedical innovations for broad public health impact. Accountabilities: As Senior Director and Head of Biostatistics, you will establish the strategic direction of the function, provide senior statistical expertise across development programs, and ensure the quality, consistency, and regulatory readiness of statistical deliverables. Lead the biostatistics function by defining its strategic priorities, operating standards, processes, and working practices across sponsored studies and research programs. Provide statistical leadership and guidance to clinical development, epidemiology, clinical immunology, and selected preclinical teams. Partner with clinical development leaders and cross-functional stakeholders to align statistical strategies with program objectives, scientific priorities, evidence-generation requirements, and regulatory expectations. Advise on clinical and experimental study design, endpoint selection, sample size assumptions, statistical methodologies, and interpretation of results. Lead or conduct senior reviews of study protocols, statistical analysis plans, clinical study reports, case report forms (CRFs), Investigator's Brochures, randomization specifications, data management plans, grant proposals, and other key documentation. Review tables, listings, figures, and statistical outputs to ensure accuracy, consistency, and scientific integrity across studies. Provide statistical expertise for scientific publications, including analysis interpretation, technical review, and coordination when required. Oversee external biostatistics vendors, including deliverable quality, timelines, budgets, scopes of work, compliance with standard operating procedures, and escalation of performance issues. Drive continuous improvement of statistical processes, tools, templates, standards, and procedures to enhance efficiency, consistency, and quality. Collaborate with Data Management, Clinical Operations, Quality Assurance, and study teams to promote data quality, analysis readiness, and inspection-ready documentation. Identify and escalate risks related to statistical quality, regulatory compliance, resource constraints, vendor performance, and delivery timelines. Lead, mentor, and develop biostatistics colleagues through clear expectations, coaching, constructive feedback, and professional development opportunities. Support resource planning, vendor budget development, and budget monitoring to ensure alignment with study priorities and organizational objectives. Foster a collaborative, scientifically rigorous, and quality-focused culture across the biostatistics function. Requirements: The ideal candidate is an accomplished biostatistics leader with extensive clinical development experience, advanced statistical expertise, and a proven ability to guide teams and programs in complex, regulated life sciences environments. Hold a master's degree in Statistics, Biostatistics, or a related discipline. A Ph.D. is preferred. Have at least 10 years of progressive clinical biostatistics experience in biotechnology, pharmaceuticals, vaccines, or related life sciences settings. Bring at least 5 years of experience in people management, functional leadership, matrix leadership, and/or vendor oversight. Demonstrate proven statistical leadership in drug, vaccine, biologics, or related clinical development programs. Possess advanced knowledge of clinical trial and experimental design, statistical power and sample size calculations, survival analysis, longitudinal data methods, and linear and generalized linear models. Have experience contributing to or supporting U.S. and/or European Union regulatory submissions, regulatory-facing documentation, or regulatory interactions. Demonstrate familiarity with current International Council for Harmonisation (ICH) guidance relevant to clinical development. Possess advanced knowledge of ICH Good Clinical Practice (GCP), ICH E-series guidelines, Good Clinical Laboratory Practices, Quality Management Systems, and 21 CFR Part 11 requirements. Have experience establishing or improving biostatistics standards, processes, tools, templates, or standard operating procedures (SOPs), strongly preferred. Demonstrate the ability to build, lead, prioritize, and develop a high-performing biostatistics function in a complex, matrixed organization. Possess excellent written, verbal, and presentation skills, with the ability to communicate complex statistical concepts clearly to scientific and nontechnical stakeholders. Show strong organizational and resource-planning skills, including the ability to manage competing priorities and align deliverables with study and program timelines. Demonstrate effective cross-functional leadership, adaptability, and sound judgment when responding to evolving scientific, operational, and organizational needs. Benefits: Annual salary for U.S.-based candidates: $210,000–$235,000, with potential variation based on experience. Annual bonus: Eligibility for additional performance-based compensation. Retirement savings: Generous retirement savings plan. Health insurance: Three health insurance plans to choose from. Additional benefits: Access to a competitive benefits package beyond the specific benefits listed. Global scientific impact: Opportunity to contribute to the development of vaccines, antibodies, and other biomedical innovations addressing urgent public health challenges. Strategic leadership: Lead and shape a core scientific function across global clinical development and research programs. Professional development: Mentor colleagues, strengthen team capabilities, and contribute to the evolution of biostatistics practices. Collaborative environment: Work with multidisciplinary scientific, clinical, and operational teams and external research partners. Location flexibility: U.S. remote work may be considered, with additional location options including New York, Cape Town, Nairobi, Amsterdam, and the United Kingdom. Remote arrangements in South Africa and Kenya may also be considered. International collaboration: Contribute to research initiatives spanning Africa, India, Europe, and the United States.