What are the responsibilities and job description for the Head of Global Biostatistics position at Daiichi Sankyo US?
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. 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.
Responsibilities
Job Description
Statistical deliverables: Working with statistical subgroup leaders to provides oversight of activities performed by the statistical function regionally and global. 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 the member of BDM leadership team (LT), communicates and collaborate 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: Provide 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: 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 to ensure a strong and future-ready statistical function. Foster 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. Provide leadership, coaching, and mentorship across regions, including direct or matrix management responsibilities as needed. Resource planning: Accountable for adequate resource available for business needs.
Responsibilities Continued
Qualifications
Education 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.
Salary Range
USD$271,500.00 - USD$452,500.00
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.
Responsibilities
Job Description
Statistical deliverables: Working with statistical subgroup leaders to provides oversight of activities performed by the statistical function regionally and global. 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 the member of BDM leadership team (LT), communicates and collaborate 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: Provide 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: 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 to ensure a strong and future-ready statistical function. Foster 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. Provide leadership, coaching, and mentorship across regions, including direct or matrix management responsibilities as needed. Resource planning: Accountable for adequate resource available for business needs.
Responsibilities Continued
Qualifications
Education 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.
Salary Range
USD$271,500.00 - USD$452,500.00
Salary : $271,500