Director, Biostatistics

Scope of the Role

Within Global Biometric Sciences (GBS), the Director, Biostatistics serves as Program Biostatistics Lead for one or more clinical development programs or assets, providing strategic statistical leadership across the development lifecycle.

The role is accountable for defining and driving the program-level statistical strategy, ensuring fit-for-purpose approaches across clinical studies to support evidence generation, regulatory submissions and product lifecycle objectives. Acting as a key statistical partner to cross-functional teams, the Director influences clinical development strategy, regulatory decision-making and the interpretation of clinical data, while providing technical leadership and guidance to study biostatisticians and external partners.

Your Role

• Act as Program Biostatistics Lead for one or more clinical development programs/assets, ensuring alignment of statistical strategy across studies with overall clinical and product development objectives.
• Represent Biostatistics within cross-functional project and asset teams, partnering with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Pharmacovigilance and Translational Sciences.
• Provide strategic statistical input into Clinical Development Plans, evidence-generation strategies, endpoints, estimands, study designs and analysis approaches.
• Lead statistical input into study protocols, including complex study designs, sample size and power calculations, randomization strategies and analysis methodologies.
• Provide statistical leadership across new drug development, indication expansion and lifecycle management, ensuring consistency and scientific rigor across programs.
• Lead the statistical strategy for regulatory submissions and Health Authority interactions, including NDA/BLA and MAA submissions and integrated analyses such as ISS/ISE, where applicable.
• Oversee key statistical deliverables, including Statistical Analysis Plans (SAPs), analysis specifications, clinical study outputs and regulatory documentation, ensuring quality and regulatory compliance.
• Provide technical guidance, oversight and mentoring to study biostatisticians, promoting high scientific standards, accountability and appropriate escalation of statistical issues.
• Oversee statistical activities delivered by CROs and external partners, contributing to vendor selection, governance and performance management.
• Ensure appropriate interpretation and communication of clinical data to support cross-functional decision-making, regulatory activities and scientific publications.
• Maintain up-to-date knowledge of evolving statistical methodologies, regulatory requirements and emerging approaches, including Real World Evidence (RWE), assessing their applicability to development programs.
• Contribute to Biostatistics standards, methodologies, processes and continuous improvement initiatives across GBS.
• Support inspection and audit readiness for assigned programs, including follow-up of relevant findings and CAPAs as required.

Who You Are

Education & Experience

• PhD in Statistics or Biostatistics with at least 10 years of relevant experience in clinical trials or health research; alternatively, Master’s degree in Statistics, Biostatistics or a related discipline with at least 11–12 years of relevant biostatistical experience.
• Significant experience in Biostatistics within clinical drug development, with accountability for the statistical strategy and delivery of clinical studies and/or development programs.
• Proven experience providing strategic and technical statistical leadership and influencing senior cross-functional stakeholders.
• Solid experience with regulatory submissions, including NDA/BLA and/or MAA, and interactions with Health Authorities such as FDA and EMA.
• Strong experience contributing to Clinical Development Plans, study designs, protocols, SAPs and regulatory deliverables.
• Demonstrated experience overseeing statistical activities delivered internally and through CROs/external partners.
• Proven ability to guide, mentor and develop biostatisticians.

Technical & Leadership Capabilities

• Comprehensive expertise in statistical methodologies for clinical trial design and analysis.
• Strong knowledge of regulatory requirements and industry standards, including ICH guidelines, CDISC and 21 CFR Part 11.
• Strong knowledge of CDISC standards, including SDTM and ADaM, and their application across clinical studies and regulatory submissions.
• Strong working knowledge of SAS and R, with the ability to provide technical oversight and critically review statistical analyses and deliverables.
• Excellent strategic thinking and ability to translate complex statistical concepts into clear recommendations for cross-functional stakeholders.
• Strong influencing, communication, problem-solving and stakeholder management skills.
• Ability to manage multiple programs and priorities effectively within a complex, global and cross-functional environment.
• Collaborative leadership style and ability to operate effectively in a diverse and evolving organization.