Associate Director, Pharmacoepidemiology
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 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
Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytical support to Daiichi Sankyo products. This position contributes to or independently lead the design, preparation and analysis of epidemiologic data including real-word data (RWD), 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 deliveries. Additionally, 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
- Study Design and statistical analysis: Plans study protocols, design and implement data analyses. Develops reports. Conducts literature search reviews including searches, reviews, preparation of summaries and reports as needed. Conducts estimation of background rates. Reviews safety documents and study protocols as needed. Works with cross-functional teams to formulate responses to health authority queries
- Documentation Analysis: Leads the process in creating literature reviews summaries, analyzes data, and writes up reports
- Efficiency of Process, SOP: Leads the process and provides guidance. Proactively ensures regulatory and good pharmacoepidemiology practices
- This position will also support planning for epidemiology strategy for assigned products.
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)
- Must have a PhD (ScD or DrPH) degree in Epidemiology or a PharmD, PhD or MD with a Master's degree in Epidemiology required
- Minimum of 1 or more years of professional experience post terminal degree in Epidemiology function in pharmaceutical companies required.
- 1 more years of industry of experience or post-doctoral degree experience in a relevant industry, academia or public sector required
- Demonstrated knowledge and expert proficiency with database management (e.g., MS-Access) and statistical programming (e.g., SAS)
- 1 more years of proven ability to formally plan, execute, and deliver pharmacoepidemiology projects
- 1 or more years of demonstrated Project Management expertise
- If degree is outside of pharmacoepidemiology, then a certificate in 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.
Date Posted
08/25/2023
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