Senior Principal Scientist, Epidemiology

Upper Gwynedd, PA, US
May 18 2018
Organization Type
Requisition ID: EPI000269

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

Under the general direction of the Executive Director, PEDRU, the Senior Principal Scientist, Epidemiology, assigned to the Pharmacoepidemiology Database Research Unit, functions as a seasoned pharmacoepidemiologist and observational database expert.  This colleague works with other groups to identify epidemiologic research needs, translate these into protocols, secure approval, execute studies, and report results with a high degree of independence as to methodology and approaches.  Works closely with Clinical Research, Clinical Risk Management, Drug Safety, Regulatory Affairs, Biostatistics, Product Line, Marketing,  and other colleagues within the Pharmacoepidemiology Unit and within the general Pharmacoepidemiology Department.

Key responsibilities include but are not limited to the following:

1.  Serving as pharmacoepidemiology support for assigned project area(s), designs and coordinates all aspects of epidemiologic research programs, including protocol preparation, study design, selection of claims and electronic medical records databases , directing design and preparation of data collection/abstraction forms and data tabulations, preparing data summaries/reports for regulatory submissions, publications and technical reports with delegation of certain tasks where possible. Directs maintenance of up-to-date reference documents and study manuals. 

2.  Directs data management activities to ensure high quality.  Writes complex programs to process and summarize epidemiologic data.  Determines own approach to tasks and independently applies basic and more complex techniques.  Recognizes when additional statistical and programming consultation is needed and communicates requirements effectively.  Maintains awareness of external data resources and identifies appropriate studies for addressing questions of interest, recognizing the limitations and strengths of the databases.  Provides consultation to other groups on the validity of studies based on prescription and diagnostic information in databases.  Independently performs data queries and summarizes epidemiologic information in tabular form and graphically.

3.  Proactively works with other groups to identify epidemiologic research needs for projects and works interactively to develop research studies to address such needs.  Critiques internally and externally written manuscripts/published literature. Maintains close working relationships with colleagues in Clinical Safety and Risk Management, Clinical Research, Regulatory, Outcomes Research, Health Economics, Pharmacogenomics, and Commercial. Assists them in areas where knowledge of epidemiology is relevant.

4.  Prepares reports to communicate epidemiologic study results to Merck management, internal committees, external investigators, and regulatory agencies.  Collaborates with other groups at Merck in preparing documentation for regulatory agencies or other organizations.

5.  Maintains professional knowledge by reading journals and textbooks, attending internal and external courses, and undertaking methodologic research.  Presents at professional scientific meetings, publishes research findings, teaches courses, collaborates with external investigators, communicates with scientific personnel at regulatory agencies.  Participates in training new department members and mentoring more junior staff.  May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post doctoral fellows.


Education Minimum Requirement: 

• Required: PhD, or MD with additional research training in epidemiology, and at least 7 years of relevant work experience in epidemiology with demonstrated ability to conduct independent research.  

Required Experience and Skills: 

• Minimum of 7 years of relevant experience in epidemiology 

• Relevant work experience in pharmacoepidemiology

• Knowledge of health care delivery systems in the U.S. and in key international markets

• Extensive knowledge and experience with the use of large claims and electronic medical record databases typically needed in pharmacoepidemiology research

• Facility in use of computer systems and data processing software

• Competency in biostatistical analysis of large observational data sets.  Competency in statistical programming. 

• Extensive experience in successful direction of large epidemiologic projects

• Broad knowledge and experience in the application of epidemiologic approaches to problems in the pharmaceutical or biotechnology industry

• Record of substantial research publications in peer-reviewed journals

• Creative problem solving ability and excellent communication skills (oral and written) 

• Ability to work in a cross-functional team environment and to collaborate with colleagues with wide variety of background and expertise.

Preferred Experience and Skills:

• Familiarity with the basic principles of genetic and molecular epidemiology

• Familiarity with artificial intelligence concepts (including natural language processing and machine learning and related technologies)

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 


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Job: Epidemiology
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck