The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
This position serves as the Biostatistics Head supporting Oncology Solid Tumor and Translational Medicine. The incumbent will be responsible for supervision and strategic input to the entire development plan for all assigned projects. The position is accountable for the development of statistical strategy and deliverables, developing statistical expertise, promoting innovations in clinical studies, maintaining operational excellence and building efficient processes and standards with the primary purpose of accelerating worldwide product approvals. This position will represent the function in global regulatory/heath authority meetings and is responsible for resource planning/allocation, timeline management and prioritization for statistical deliverables. The position is also accountable for people management, including performance and development of direct reports.
Statistical deliverables including protocol Development, documents and analyses for Clinical Study Reports (CSR), and documents and analyses to support regulatory filings: 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 and reporting to accelerate worldwide product submissions and approvals.
Drug Development Strategy: Reviews and provides strategic input to the entire development plan for all assigned projects to ensure product profile can be delivered based on the development plan. Briefs senior management on assigned projects or studies as needed. Subject matter expert in one or more 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.
Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally. Represents the function at health authority meetings.
Global BDO Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistics functions. Oversees compliance of standard procedures and processes.
People Management: Administrative responsibilities for recruiting, retaining, developing, and managing employees.
PhD in Statistics or Biostatistics
12 years relevant experience in the pharmaceutical industry
5 years supervisory experience, if managing a team
Excellent oral and written communication skills
Strong expertise in drug development including statistical knowledge and skills in trial designs, statistical analyses, and data interpretation
Demonstrated strong leadership, strategic y thinking and excellent collaboration skills
Experience in CRO management
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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. Job Title Sr Director Biostatistics
City Basking Ridge
Functional Area Biostatistics & Data Management
State New Jersey Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.