Executive Director, Biostatistics

1 month ago

Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

Reviews and provides strategic input to the entire portfolio or specific therapeutic areas from Phase 1 through life cycle management. Provides oversight of statistical activities performed by direct reports or staff of the global function to support drug development and life cycle management. Represents the function in global regulatory/heath authorities' meetings. High-level negotiation and oversight of CROs and provides oversight of CRO/sponsor partnership. Sets the vision and strategy for the function. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.

Responsibilities:

Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities performed by direct reports and biostatisticians across the regional/global function, when assigned. Develops, directs, prioritizes and monitors all assigned projects and processes relevant to project development plan, study design, statistical analysis, data display, results validation, interpretation and reporting to accelerate worldwide product submissions and approvals.Drug Development Strategy: Reviews and provides strategic input to entire portfolio or specific therapeutic areas from Phase I through life cycle management. Briefs senior management on assigned projects or studies as needed. Subject matter expert in multiple therapeutic areas.CRO / Vendor Oversight: Manages higher-level negotiation and provides oversight of budget, resources and timelines with contract research organizations (CROs) for multiple projects 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 CRO/sponsor partnership.Global Health Authority Interaction / Negotiation: Provide strategic input for global submission, global health authority interaction and negotiation. Reviews documents and responses submitted to health authorities globally. Represents the function at health authority meetings.Global BDO Strategy to Improve 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 to improve the overall efficiency in bringing products to market. Authors or initiates writing of global standard operating procedures; Monitors and enforces compliance of standard procedures and processes.People Management: Has administrative responsibilities for recruiting, retaining, developing, and managing employees. Identifies training needs of staff, not limited to direct reports, and implement the trainings. Leverages manpower and talents across Regions to maximize efficiency. Mentors or acts as functional manager of staff resides in other offices as needed.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)PhD in statistics or biostatistics preferred Experience Qualifications10 or More Years relevant experience in the pharmaceutical industry, including new drug application submission experience or equivalent. preferred7 or More Years experience in direct management of statistical group preferredDaiichi 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.

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