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 be accountable for 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.

Job Description

• 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 be accountable for 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.
• 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.

Qualifications

• PhD in statistics/biostatistics or equivalent required
• Experience Qualifications: 15 or More Years Relevant experience in the pharmaceutical industry, including global new drug application submission experience or equivalent. required and 10 or More Years Experience in direct management of statistical group required and Minimum 6 years’ experience in oncology clinical drug development Phase 1-4 including at least 2 regulatory submissions required

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.