Job Information
Daiichi Sankyo Inc. Associate Director, Pharmacoepidemiology in Basking Ridge, New Jersey
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
The Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support to Daiichi Sankyo products. This position contributes to or independently leads the design, preparation and analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.
This position independently carries out various functions (e.g., literature reviews, study design, preparation of data for statistical analysis to obtain background rates) for development of safety documents (e.g., RMP), support SMTs, SERM or other safety-related meetings and study protocols.
This position independently manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams) and external stakeholders.
Must be able to prioritize and manage multiple projects and vendors. Provides strong vendor/internal communication to ensure successful and timely deliverables. This position solves complex technical problems with experience and expertise. Finally, this position makes tactical decisions utilizing input from upper management that impacts more than one project team at a time. This position will also support planning for epidemiology strategy for assigned products.
RESPONSIBILITIES
Identify study needs, draft protocols, and contribute to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, conduct analyses, and interpret/communicate scientific findings to internal and/or external stakeholders
Conduct literature searches and reviews (targeted and/or systematic) and prepare summaries/reports
Work on cross-functional teams to formulate responses to health authority queries
Provide epidemiologic support to internal stakeholders and disseminate study findings through presentations and/or publications in peer-reviewed scientific journals
Assess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize background event rates
Design and conduct post-authorization safety studies, and contribute to the development and review of safety documents including Risk Management Plans
Efficiency of Process, SOP: Leads the process and provides guidance. Proactively ensures regulatory and good pharmacoepidemiology practices
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 (ScD or DrPH) degree in Epidemiology or a PharmD, PhD or MD with a master's degree in Epidemiology required
Experience Qualifications
2+ years post terminal degree of professional experience in Epidemiology function within the pharmaceutical industry
2+ years of industry experience or post-doctoral degree experience in a relevant industry, academia or public sector
2+ years of expertise using database management (e.g., MS-Access) and statistical programming (e.g., SAS) required
Must have demonstrated ability to formally plan, execute, and deliver projects
Must have Project Management experience
Licenses and Certifications
- If degree is outside of epidemiology, then a certificate in epidemiology/pharmacoepidemiology is required
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.