Head of Global Biostatistics

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This role, reporting to the Head of Global Biostatistics & Data Management, sets the vision and strategy for the statistical function within R&D. It creates a strong statistical practice, motivating and inspiring people and the department to grow and learn continuously. The role reviews and provides strategic inputs to the entire portfolio of DS from pre‑clinical through life cycle management, is accountable for the quality and timeline for all statistical deliverables, promotes and oversees statistical innovation, standards and processes in drug research and development, and negotiates with external vendors. The role collaborates with other functions to support preclinical and clinical activities, manages performance and development of direct reports, mentors skip‑level and global staff, and devises KPIs for the department. It also contributes to the broader BDM strategy as a key member of the BDM leadership team. Job Description Responsibilities Statistical deliverables: work with statistical subgroup leaders to oversee regional and global statistical activities, including trial design, statistical analysis plans, statistical reporting for clinical study reports, ISS/ISEs, and other deliverables, ensuring timely and high‑quality outcomes. Drug Development Strategy: review and provide strategic input for the entire clinical portfolio, collaborate with other function leaders to support decision‑making and execution, and provide regular status updates on projects, metrics, and KPIs to Head of BDM and BDM LT. External Vendor Oversight: oversee quality, performance, budget, resources, and timelines of the department; ensure timely delivery of high‑quality deliverables at reasonable cost; develop outsourcing strategy and manage external vendors/sponsor partnerships. Global Health Authority Interaction / Negotiation: provide strategic input for global submissions, review and approve documents and responses submitted to health authorities globally, and represent the function at health authority meetings when needed. Global Biostatistics Strategy, Process, and Innovation: set vision and strategy for the function, identify areas for improvement, develop technology and innovation strategy to improve overall efficiency, oversee global statistical standard operating procedures, enforce compliance, and champion automation where relevant. People Management and Organizational Capability: build, lead, and develop a high‑performing global Biostatistics organization aligned with business and pipeline priorities, drive talent strategy across recruitment, retention, succession planning, capability building, and performance management. Resource Planning: be accountable for ensuring adequate resources are available for business needs. Qualifications Education Qualifications PhD in statistics/biostatistics or equivalent required. Experience Qualifications 15 or more years of relevant experience in the pharmaceutical industry, including global new drug application submission experience or equivalent. 10 or more years of experience in direct management of a statistical group. Minimum 6 years’ experience in oncology clinical drug development Phase 1‑4, including at least 2 regulatory submissions. Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. #J-18808-Ljbffr Daiichi Sankyo