Manager, Pharmacoepidemiology

Location
Basking Ridge, NJ, United States
Posted
Feb 21, 2021
Ref
10713BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

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.

Job Summary:

Manager, Pharmacoepidemiology position provides epidemiologic, methodological, and analytical support to Daiichi Sankyo products. This position contributes with the design, preparation and analysis of epidemiologic data including real-word data (RWD), supporting senior management in various epidemiological activities. This position also generates data standardization, visualization, and reporting to support analysis for epidemiologic studies and safety surveillance. This position 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.

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

Coordination of epidemiologic functions: Contributes with the organization of meetings, preparation of minutes, setting up conference calls and/or meetings as needed

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

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

Education/Experience:

Master's Degree in pharmacy, epidemiology, pharmacoepidemiology, biostatistics, statistics, bioinformatics, public health or related field required or PharmD or PhD in epidemiology, pharmacoepidemiology, biostatistics, statistics, bioinformatics, public health or related field or MD 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.

Job Title
Manager, Pharmacoepidemiology

City
Basking Ridge

Functional Area
CSPV

State
New Jersey