Director, Epidemiology RWE (Onco or Immunology)

Job Responsibilities

• 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
• 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, translating 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

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
• Demonstrated ability to manage priorities and performance targets
• Experience in leading drug development project for 2+ years for therapeutic area of assignment preferred

Benefits

• 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
• Flexible paid time off (PTO) and sick time

Pay

$118,700.00 - $207,800.00

Schedule

N/A