Senior Director and Head of Biostatistics

Job description

**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 India.** The Senior Director and Head of Biostatistics will provide strategic and scientific leadership for biostatistical activities across a global clinical research and product development portfolio. This senior leadership role will shape statistical strategy, establish functional standards, and ensure rigorous statistical methods inform clinical study design, data analysis, and development decisions. Working closely with Clinical Development, Epidemiology, Clinical Immunology, Data Management, and other cross-functional teams, you will support high-quality evidence generation and regulatory readiness. You will oversee study-level statistical deliverables, external vendors, quality processes, and resource planning while fostering a culture of scientific excellence and continuous improvement. The role also involves mentoring and developing biostatistics professionals and aligning functional priorities with evolving program needs. This is an opportunity to contribute to global health research and help advance innovative vaccines, antibodies, and other biomedical solutions for significant unmet public health needs. ### Accountabilities - Strategic biostatistics leadership: Lead the Biostatistics function by defining its strategic direction, priorities, standards, processes, and operating practices across sponsored studies and research programs. - Provide senior statistical guidance to clinical development, epidemiology, clinical immunology, and selected preclinical teams, ensuring statistical strategies align with scientific objectives, evidence-generation needs, and regulatory expectations. - Partner with clinical development and cross-functional leaders to integrate robust statistical approaches into program planning, study execution, and product development decisions. - Serve as a senior subject matter expert for biostatistical processes, standards, tools, templates, and standard operating procedures (SOPs). - Study and program-level leadership: Guide study design, endpoint selection, sample size assumptions, statistical analysis methods, and interpretation of study results. - Lead or provide senior-level review of study protocols, statistical analysis plans, study reports, case report forms (CRFs), Investigator’s Brochures, randomization specifications, data management plans (DMPs), grant proposals, and other essential study documentation. - Review statistical outputs, including tables, listings, figures, and analyses, to ensure accuracy, consistency, scientific integrity, and quality across studies. - Support scientific publications through statistical analysis, interpretation, review, and coordination as required. - Functional operations and quality: Oversee external biostatistics vendors, including deliverables, quality expectations, scopes of work, budgets, timelines, SOP compliance, and escalation of issues. - Continuously improve statistical processes, templates, tools, and standards to enhance efficiency, consistency, quality, and regulatory compliance. - Collaborate with Data Management, Clinical Operations, Quality Assurance, and study teams to ensure data quality, analysis readiness, and inspection-ready deliverables. - Identify, assess, and escalate risks involving statistical quality, compliance, resource availability, vendor performance, and study timelines. - People and resource management: Lead, coach, and develop biostatistics colleagues through clear expectations, regular feedback, professional development, and effective workload planning. - Contribute to resource planning, vendor budget development, and budget monitoring, ensuring biostatistics capacity and spending remain aligned with program priorities. - Build a collaborative, scientifically rigorous, and quality-focused function that supports organizational goals and continuous learning. ## Requirements: - A master's degree in Statistics, Biostatistics, or a related discipline is required; a Ph.D. is desirable. - At least 10 years of progressive experience in clinical biostatistics within biotechnology, pharmaceutical, vaccine development, or related life sciences environments. - At least 5 years of experience in people management, functional leadership, matrix leadership, and/or vendor oversight. - Demonstrated experience providing statistical leadership for drug, vaccine, biologics, or related clinical development programs. - 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. - Experience contributing to or supporting US and/or EU regulatory submissions, regulatory-facing documentation, or regulatory interactions. - Familiarity with current International Council for Harmonisation (ICH) guidance relevant to clinical development. - Strong knowledge of ICH Good Clinical Practice (GCP), ICH E-series guidelines, Good Clinical Laboratory Practices, Quality Management Systems, and 21 CFR Part 11 requirements. - Experience establishing or improving biostatistics standards, processes, tools, templates, and SOPs is strongly preferred. - Proven ability to build, lead, and develop a high-performing biostatistics function in a complex, matrixed organization. - Strong written, verbal, and presentation skills, with the ability to communicate complex statistical concepts clearly to scientific, clinical, and cross-functional audiences. - Demonstrated ability to assess resource requirements, manage competing priorities, and align statistical deliverables with study and program timelines. - Strong cross-functional leadership and collaboration skills, including the ability to adapt plans as scientific priorities, study requirements, and organizational needs evolve. ## Benefits: - Employment type: Full-time position. - Work arrangement: Remote work is considered for eligible locations; the original listing includes several location options across the United States, South Africa, Kenya, the Netherlands, and the United Kingdom. - Global impact: Opportunity to contribute to clinical research, vaccine and antibody development, and public health initiatives addressing significant unmet medical needs. - Professional leadership: Scope to shape biostatistics strategy, develop teams, and establish functional standards across a diverse research and product development portfolio. - Compensation: The original listing specifies an annual salary range of $210,000–$235,000 for US-based candidates, with potential variation based on experience. This range is specific to US-based candidates and should not be interpreted as the salary offered in India. - Additional benefits: For US-based candidates, the listing mentions an annual bonus, a retirement savings plan, a choice of three health insurance plans, and other benefits. Benefits applicable to India are not specified in the provided description. - Accessibility and inclusion: Reasonable accommodations are available for applicants who need assistance with the application or recruitment process.