Director, Epidemiology RWE - Pharma Co

Job Responsibilities This role is open to candidates who live in the US with no sponsorship needs. Skillset: Sr Epi - Inflam-Liver Group. Hybrid trial adding controls to placebo group. CDisc Reqs, PharmaCo Epi Clinical background - preferred PhD Required Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE Lead, design, and manage epidemiological, biomarker and/or data science projects Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries) Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy Construct cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers Support the effective communication of study/analysis results to support internal and external decisions Coauthor abstracts and manuscripts for external dissemination of methodologic study results Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities Technical Expertise Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes Ability to design studies independently, (ie ability to translate research questions to create study design) Subject Matter Expertise Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions Minimum Qualifications PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post‑doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master’s degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7‑9 years of experience in lieu of PhD may be acceptable. Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred Demonstrated ability to function with an increasing level of autonomy and to develop productive cross‑functional collaborations in a matrix environment Ability to manage priorities and performance targets Experience in leading drug development project for 2+ years for therapeutic area of assignment preferred Benefits The benefits for this position may include a company car or car allowance, health benefits to include medical, dental, and vision, company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Salary Range: $118,700.00 - $207,800.00. We are committed to compliance with the Americans with Disabilities Act and provide accommodations as appropriate. #J-18808-Ljbffr