Sr Manager, Medical Affairs

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Job Description:

The RWE Analyst will contribute to a Real-World Evidence/Health Economic Outcomes Research (RWE/HEOR) Team as part of an effort to contribute to the strategies of the broader Evidence Generation Team, which will include the conduct of timely, relevant, and rigorous analysis of real-world data (RWD) to address critical research questions and contribute to cross-functional initiatives.

The RWE Analyst will be responsible for developing, reviewing, and providing feedback on study documents, such as protocols and statistical analysis plans, and executing planned data analyses using administrative claims, electronic health record (EHR), and observational registry databases. The RWE Analyst will work closely with project teams to manage timelines and workflows, and to communicate results and updates to internal cross-functional stakeholders, including people from Biometrics, Clinical Operations, and Safety.

The RWE Analyst will have access to real-world databases and act as stewards of best research practices, standards, and methodologies underlying the use of RWE.

Key Responsibilities:

• Support development of and provide critical appraisal of study protocols for research projects using RWD (e.g., medical claims, EHR, and observational registry databases)
• Lead or support development of statistical analysis plans in collaboration with internal stakeholders (e.g., Biometrics and programming team members)
• Conduct data reviews for primary/secondary data collected to ensure quality and reliability
• Communicate study results with a broader internal cross-functional audience
• Adapt performance metrics and dashboards for RWE projects
• Support preparation of reports and/or publication materials (e.g., abstracts, manuscripts)
• Support cross-functional initiatives to develop and refine internal procedures, workflows, and best practices

Basic Qualifications:

• Master’s degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 4+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industry OR
• Bachelor’s degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 6+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industry

Preferred Qualifications:

• Master’s degree or Doctoral level training in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution
• 4+ years of oncology research experience highly preferred
• In-depth knowledge of claims-based RWD (e.g., HealthVerity, Optum) and prior experience of using claims-based RWD in oncology research
• Experience working with EHRs (e.g., IQVIA, Flatiron) and registry databases
• Prior experience of using RWD for RWE in regulatory applications, post-marketing studies, and pharmacovigilance
• Experience with external control arm (ECA) methodologies
• In-depth understanding of the principles of epidemiologic research methods and statistical concepts in support of the analyses and demonstrated proficiency in statistical analysis programming languages commonly used in life sciences (e.g., SAS, R)
• Experience in biopharmaceutical industry
• Excellent verbal, written and presentation skills, including the ability to effectively communicate statistical methodology and analysis results
• Ability to work independently and collaboratively in a constantly changing, diverse, and matrix environment

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