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.

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, ensuring quality and timely delivery of statistical deliverables.

It promotes, oversees, and is accountable for statistical innovation, standards, and processes in drug research and development. The role engages in high-level negotiation and oversight of external vendors, collaborates with other functions, and manages the performance and development of direct reports. It also contributes to broader BDM strategy and cross-functional decision-making as a key member of the BDM leadership team.

• Statistical deliverables:
  Work with statistical subgroup leaders to provide oversight of activities performed by the statistical function regionally and globally; advise, direct, prioritize, and monitor trial design, statistical analysis plans, statistical reporting for clinical study reports/ISS/ISEs, and deliverables in terms of timeline and quality.
• Drug Development Strategy:
  Review and provide strategic input to the entire clinical portfolio; communicate and collaborate with other function leaders during decision making and execution; provide regular status updates on projects, metrics, and KPIs to the Head of BDM and BDM LT.
• External Vendor Oversight:
  Provide oversight of quality, performance, budget, resources, and timelines across the department; ensure timely delivery of high-quality deliverables at reasonable cost; develop outsourcing strategy; oversee external vendors/sponsor partnerships; leverage external statistical experts in supporting R&D activities.
• Global Health Authority Interaction/Negotiation:
  Provide strategic input for global submissions; review and approve documents and responses submitted to health authorities globally; represent the function at health authority meetings as needed.
• Global Biostatistics Strategy, Process, and Innovation:
  Set the vision and strategy for the function; identify areas for improvement and initiate rectification or remedial activities; develop technology and innovation strategy to improve efficiency; oversee or initiate global statistical SOPs and standards; monitor and enforce compliance; act as an expert across methods including interim analyses, Bayesian methods, AI/ML/automation; encourage 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; foster a culture of collaboration, innovation, and continuous learning; optimize global talent deployment and cross-regional resource leverage; provide leadership, coaching, and mentorship across regions; ensure adequate resource availability for business needs.

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 of experience in oncology clinical drug development Phase 1-4, including at least 2 regulatory submissions.

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.

USD$ - USD$

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