Senior Scientist, Epidemiology Full-time

Senior Scientist, Epidemiology

Under the general direction of the Executive Director of Epidemiology, the Senior Scientist, Epidemiology is responsible for the design, execution, analysis, and reporting of epidemiologic research on assigned products in atherosclerosis and ASCVD. The role also provides consultation on epidemiologic methods, real-world evidence (RWE) generation, and the interpretation of observational study results across the organization as needed.

Primary activities include but are not limited to:

• Has main responsibility for the design, execution, and analysis of epidemiologic research studies on assigned company products in atherosclerosis and ASCVD.
• Assisting Therapeutic Area (TA) lead epidemiologist in worldwide epidemiologic planning and study recommendations.
• Has supporting responsibility for cross-functional interaction with risk management sub-teams, value evidence sub-teams, clinical, and regulatory sub-teams, and other R&D areas on epidemiologic matters related to product safety, risk management, post-marketing safety studies, regulatory activities, and clinical development.
• May present epidemiologic research plans or results to internal review and governance committees; to external agencies such as FDA (including advisory committees), EMA, CDC, AHRQ, and WHO; and at scientific conferences.
• Maintains close working relationships with colleagues in Clinical Research, Regulatory, Safety, Statistics, Outcomes Research, Health Economics and Commercial. Assists them in areas where knowledge of epidemiology is relevant.
• Contributes to our company'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.

Minimum required education:

• PhD in Epidemiology or MD with additional research training in epidemiology with research experience (including doctoral research) in atherosclerosis and ASCVD.

Required experience and skills:

• Proven experience leading epidemiologic projects in atherosclerosis and ASCVD using large databases: including national surveys, administrative claims, electronic health records (EHRs), and disease registries.
• Demonstrates a record of research publications in peer-reviewed journals.
• Exhibits creative problem-solving ability and excellent communication skills, both oral and written.
• Able to work effectively in a cross-functional team environment and collaborate with colleagues with a wide variety of backgrounds and expertise.

Preferred Experience And Skills

• Possess broad knowledge and experience in applying epidemiologic approaches to problems in the pharmaceutical or biotechnology industry.
• Familiarity with Good Pharmacovigilance Practices (GVP), Good Pharmacoepidemiology Practices (GPP), and guidance from FDA/EMA on RWE/RWD.

Required Skills: Cardiovascular Disease Epidemiology, Clinical Research, Collaborating, Communication, Cross-Functional Teamwork, Data Analysis, Electronic Health Records (EHR), Epidemiological Research, Epidemiological Studies, Epidemiologic Methods, Epidemiology, Pharmacoepidemiology, Pharmacovigilance, Product Safety, Risk Management, Scientific Publishing, Stakeholder Relationship Management, Strategic Planning

Preferred Skills: