Associate Principal Scientist, Epidemiology
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, Pharmacoepidemiology and Database Research Unit (PEDRU), Epidemiology, the Associate Principal Scientist, Epidemiology, has responsibility for the design, placement, conduct, analysis, and reporting of pharmacoepidemiologic research studies on assigned Merck products and for providing consultation on epidemiologic issues to all areas of the company, as needed, with a concentrated focus on those projects that require the use of large automated databases.
Primary activities include but are not limited to:
- May have overall responsibility for or assist in worldwide pharmacoepidemiologic planning and study recommendations for assigned Merck products. The Pharmacoepidemiology Department supports all drugs, vaccines, and biologics in all therapeutic areas. Although staff are expected to develop primary subject matter expertise in one or more therapeutic areas, staff may receive assignments in any therapeutic area depending on need.
- Has lead responsibility or support responsibility for interaction with risk management subteams, value evidence subteams, clinical/regulatory subteams, and other areas of Merck Research Laboratories on epidemiologic matters related to product safety and risk management, post-marketing safety studies, regulatory activities, clinical study design, endpoint qualification/standardization/training for clinical trials, and biomarkers/molecular epidemiology/genetic epidemiology.
- Has responsibility for the design, conduct, and analysis of epidemiologic research studies on assigned Merck products worldwide.
- Has responsibility for the design and conduct of epidemiology research using large automated database systems.
- May present epidemiologic research plans or results to internal review and governance committees; to external agencies such as FDA (including advisory committees), EMA, CDC, and WHO; and at scientific conferences.
- Maintains close working relationships with colleagues in Clinical Research, Regulatory, Outcomes Research, Health Economics and Commercial. Assists them in areas where knowledge of epidemiology is relevant.
- Contributes to Merck's prestige by maintaining recognition as an expert in his/her field; may publish independent scientific research in leading journals, participate in and present at scientific organizations and meetings, and serve as a peer reviewer for scientific journals.
- May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post doctoral fellows.
- Required: A minimum of a Master’s degree in Epidemiology with at least 5 years relevant work experience.
- Prefer a PhD in Epidemiology or a Doctorate degree in another relevant science discipline or a MD with additional research training in epidemiology all with at least 3 years of relevant work experience.
Required Experience and Skills**:
- Requires 3 years of experience in successfully conducting epidemiologic projects that include data analysis using large automated databases.
- Extensive knowledge of health care delivery systems and large record linkage health care claims and electronic medical record databases.
- Facility in use of computer systems and data processing and analytic software.
- Strong statistical programing skills.
- Creative problem-solving ability and excellent communication skills (oral and written) are expected.
- Strong knowledge of epidemiology research methods and of modern statistical techniques used to analyze complex observational datasets. Such method/analytic challenges include (but are not limited to) prospective sequential surveillance methods for screening, pragmatic trials, self-controlled series designs, advanced methods for confounding control (such as propensity scores, disease scores, and trend-in-trend analysis), new user designs, approaches to handle time varying confounding, quantitative bias analysis, and strategies for dealing with competing risks.
Preferred Experience and Skills:
- Broad knowledge and experience in the application of epidemiologic approaches to problems in the pharmaceutical or biotechnology industry are an asset.
-Familiarity with innovative data visualization techniques, and facility with utilizing modern approaches and technologies to communicate research questions and results.
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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Employee Status: Regular
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Company Trade Name: Merck