Genesis is one of the leading evidence generation consultancies providing agile, tech-enabled real-world evidence (RWE), as well as health economics and outcomes research (HEOR) solutions to clients in the pharmaceutical, biotech, and medical device industries. Since 2009, we’ve partnered with our clients to develop impactful evidence across the product lifecycle to optimize market access for novel healthcare innovations and satisfy regulatory, provider, and payer evidence requirements. Genesis is database agnostic, regularly working across many structured and unstructured real-world data sources. As a company, we deliver services across many RWE and HEOR applications and a wide range of therapeutic areas with an emphasis on uncompromising quality, scientific rigor, and flexible solutions.

The Pharmacoepidemiology and Safety team and this position:

The Genesis pharmacoepidemiology and safety team consists of scientific experts who lead study design, methodology development, and result interpretation across a broad range of regulatory and safety RWE studies. The individual in this role will demonstrate a passion for the generation of rigorous and relevant RWE, ensuring delivery of high-quality evidence in a timely manner to fully meet our clients’ needs. This position will report to a Director or Senior Director in Pharmacoepidemiology and Safety.

Accountabilities within this role:

• Develop scientifically-sound, clear, concise RWE deliverables related to study design, methodology, and result interpretation (for example: study concept sheets, protocols, analysis results/interpretation, final study reports, slide decks, regulatory briefing books, risk management plans, manuscripts etc.).
• Contribute effectively to a team of pharmacoepidemiologists, biostatisticians, and analysts charged with designing, implementing, and managing a wide range of studies to assess the utilization, effectiveness, and safety of medicinal products.
• Collaborate within the organization as it relates to pharmacoepidemiology and safety by supporting cross-functional teams through the design, execution, and delivery of high-priority and high-visibility RWE studies.
• Ensure best practices with respect to RWD data source selection and research methodology, assessing strengths and limitations when designing studies; appropriately accounting for implications of underlying RWD generation mechanisms and medical coding practices.
• Cultivate a positive work environment.

Qualifications:

• Master’s degree or PhD within a relevant discipline (e.g., Pharmacoepidemiology or Epidemiology focus on methods and study execution)
• 4+ years for Master’s degree or 2+ years for PhD of consulting, industry, or academic experience
• Experience generating and interpreting real-world and observational research
• Experience designing and executing studies using claims and/or EHR databases
• Strong regulatory and life sciences industry knowledge
• Excellent verbal and written communication skills
• Proficiency in relevant software such as MS office (Word, Excel and PowerPoint)
• Exceptional organizational skills and attention to detail
• Enthusiasm to learn and motivation to develop oneself and others within Genesis Research
• Flexibility to adapt to client project needs and handle competing priorities in a fast-paced workplace

Compensation:

• Competitive salary
• Performance-related bonus
• Flexible Paid Time Off
• Employer matched pension plan
• Private Medical Insurance