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Senior Director, Biostatistics

Job Description
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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

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 15,000 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

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.

Responsibilities

  • 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.



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 required



Experience Qualifications

  • 10 or More Years relevant experience in the pharmaceutical industry required
  • 4 or More Years supervisory experience, if managing a team preferred



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.

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.

Senior Director, Biostatistics

Bernards, NJ
Full Time

Published on 05/04/2022

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