Director, Epidemiology Analytics

Summary

This position leads Epidemiology analytics activities and/or projects using real-world evidence (RWE) analytics such as artificial intelligence/machine learning (AI/ML) in support of new drug development and/or post-marketing drug safety for the marketed products. The epidemiologist analytics is responsible for the design, conduct, statistical analysis, and reporting of pharmacoepidemiologic research studies of assigned DSI products and for providing consultation on epidemiologic issues, as needed.

In collaboration with the development team and/or clinical safety team, this position provides feedback on the clinical trial and/or non-interventional studies designs, and safety analysis plan.

This position also independently manages relationships with internal and external key stakeholders to conduct epidemiologic studies and may provide recommendations to lower levels. This position solves complex technical problems and partnership/clientele issues related to epidemiologic studies with advanced experience and expertise.

Finally, this position approves epidemiologic complex decisions for project teams and makes strategic decisions that impact more than one project team.

Responsibilities

• Protocol Development, Analysis Plan (AP), Analysis, Results Interpretation, and Study Report: Lead analytical activities for a very complex project. Act as an analytical expert in the assigned projects.
• Guides the project team in using the most efficient or innovative study design by considering the current and evolving trends within the industry and business drivers.
• Demonstrate high-level proficiency for RWE analytics, AI/ML technology while providing support for real-world database activities ranging from the descriptive nature of studies to the external control study to provide comparative analysis.
• Research statistical/analytical methodologies and addresses specific questions across the value chain by working effectively with the customers/stakeholders.
• Evaluate and provide input to enhance the computing environment system for RWE analytics efficiency, identify a way to enhance the system and/or analysis tools, and work as the SME to support implementation and evaluation of the utilities.
• Support the statistical analysis of DS products as needed.
• Mentoring junior statisticians, data managers, programmers, or fellows.
• Provides support to clinical team on clinical trial design and SAP, and other functions: Proactively works with other groups to identify epidemiologic research needs for projects and works interactively to develop research studies to address such needs. The epidemiologist develops and validates new measurement techniques, including but not limited to new instruments for measurement of health-related quality of life; critiques internally and externally written manuscripts/published literature and provides epidemiologic consultation on clinical trial design, SAP, and interpretation.

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)

- PhD (ScD or DrPH) degree in Epidemiology, Statistics/Biostatistics, Pharmacoepidemiology related field.

Experience Qualifications

• Experience 7 or more years of relevant experience in the pharmaceutical industry

Competencies

• Expert knowledge of statistical, AI/ML methodologies, clinical trials and observational studies
• Excellent programming knowledge in SAS and/or R, Python
• Excellent oral and written communication skills
• Working knowledge of secondary data sources including registries, EMR and claims.
• Excellent collaborating skills and ability to work as a team
• Excellent project planning skills