Associate Director - Safety Statistician, Statistical Strategy and Innovation

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary:

Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company for safety analyses.

Responsibilities:

- Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization and reporting in collaboration with safety programming team, CSPV, and epidemiology for several projects with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials.
- Safety analysis methodology and standardization Develop and support statistical safety analysis methodology and standardization across the clinical development in cross functional teams.
- Builds partnership with safety programming teams, project statistical teams, and internal cross functional teams and external institutions to maximize available resources.
- Safety working groups and initiatives. Represent statistics to participate (and lead if applicable) in safety signal working groups or cross function initiatives.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education (from an accredited college or university):

- PhD In statistics or Biostatistics required

Experience Qualifications:
- Minimum 5 years of relevant experience in the pharmaceutical industry and experiences as a safety statistician. required

Travel: Ability to travel 10%

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: