Head of Global Biostatistics

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. Creates a strong statistical practice, motivating and inspiring people and the department to grow and learn continuously. Reviews and provides strategic inputs to the entire portfolio of DS from pre‑clinical through life cycle management. Accountable for the quality and timeline for all statistical deliverables. Promotes, oversees, and ensures statistical innovation, standards and processes in drug research and development. High‑level negotiation and oversight of external vendors in vendor/sponsor partnership. Collaboration with other functions and partners in supporting preclinical and clinical activities. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional leadership to skip‑level and global staff including ex‑US team members. Accountable for developing objectives, KPIs and metrics for the department and providing strategic reporting and insights to the Head of Global BDM. This role also serves as a key member of the BDM leadership team, contributing to BDM broader organizational strategy, cross‑functional decision‑making, and the advancement of BDM objectives beyond the Biostatistics function. Responsibilities Statistical deliverables: Working with statistical subgroup leaders to provide oversight of activities performed by the statistical function regionally and globally. Advises, directs, prioritizes, and monitors all statistical activities including trial design, statistical analysis plans, statistical reporting for clinical study reports/ISS/ISEs, etc. and deliverables in terms of timeline and quality. Drug Development Strategy: Reviews and provides strategic input to the entire clinical portfolio. As a member of BDM leadership team (LT), communicates and collaborates with other function leaders during this process to support decision making and execution. Provides regular status updates on projects, metrics and KPIs to Head of BDM and BDM LT. External Vendor Oversight: Provides oversight of and is accountable for the quality/performance and budget, resources and timelines across the department and ensures timely delivery of high‑quality deliverables at reasonable cost. Develops overall outsourcing strategy for the function and provides oversight of the external vendors/sponsor partnership. Strategically leverages external statistical experts in supporting research and development activities. Global Health Authority Interaction / Negotiation: Provides strategic input for global submission. Review and approve documents and responses submitted to health authorities globally. Represents the function at health authority meetings if needed. Global Biostatistics Strategy, process and innovations for Drug Development: Sets the vision and strategy for the function. Identifies areas to be improved and initiates rectification or remedial activities. Develops the strategy for technology and innovation to improve the overall efficiency in bringing products to market. Oversees or initiates global statistical standard operating procedures and standards; monitors and enforces compliance of standard procedures and processes in Biostatistics. Acts as a strong statistical and mathematical expert across a range of methods including interim analyses, Bayesian methods, etc., including AI/ML/automation. Ensures the development of and adherence to standards and encourages use of automation where relevant. People Management and Organizational Capability: Builds, leads, and develops a high‑performing global Biostatistics organization aligned with business and pipeline priorities. Drives talent strategy across recruitment, retention, succession planning, capability building, and performance management to ensure a strong and future‑ready statistical function. Fosters a culture of collaboration, innovation, and continuous learning while optimizing global talent deployment and cross‑regional resource leverage to maximize organizational effectiveness and operational efficiency. Provides leadership, coaching, and mentorship across regions, including direct or matrix management responsibilities as needed. Resource planning: Accountable for adequate resources available for business needs. Qualifications Education Qualification: PhD in statistics/biostatistics or equivalent required. Experience Qualification: 15 or more years relevant experience in the pharmaceutical industry, including global new drug application submission experience or equivalent. 10 or more years experience in direct management of a statistical group required and a minimum of six years’ experience in oncology clinical drug development Phase 1‑4, including at least two 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. Compensation Salary Range: USD$271,500.00 - USD$452,500.00 #J-18808-Ljbffr Initial Therapeutics, Inc.