Part Time Epidemiologist Consultant

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Responsibilities: 
•    Partner with internal and external stakeholders on the design and conduct of epidemiologic research to inform clinical development programs and to support regulatory submissions to the FDA, EMA and other agencies globally.
•    Apply epidemiological expertise to the utilization of disease registries, observational population / data sources, study designs and analytical strategies to evaluate drug effectiveness and safety postmarketing.
•    Contribute to epidemiological sections of regulatory and other scientific documents such as clinical development plans, protocols and study reports, statistical analysis plans, research summaries, abstracts, and publications.
•    Provide critical assessment of epidemiological methods, data, and literature.

Basic Qualfications:
•    Master’s degree in epidemiology or a related discipline and at least 4 years of experience working in the pharmaceutical industry.
•    Hands-on experience in utilization of rare disease registries as data source for the conduct of pharmacoepidemiological postmarketing studies.
•    Knowledge of scientific areas relevant to postmarketing safety.
•    Critical thinking and analytical skills and ability to make high level decisions 
•    Hands-on experience in the design and analysis of postmarketing studies.

Preferred Qualifications:
•    Doctoral degree (PhD/DrPH) or equivalent in epidemiology or a related discipline and at least 2 years of experience working in the pharmaceutical industry.
•    Experience in contributing to BLA submissions to FDA and EMA.
•    Proven history of successful involvement driving a strategic, global, cross-functional initiative.
 

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