Location: Remote candidates must be US-based
Description
- Design and conduct epidemiological studies to generate real-world evidence within time budget and quality standards including but not limited to: natural history of disease population characterization assessment of treatment patterns and unmet need development of external comparators benchmarking of clinical outcomes comparative safety and effectiveness research and post-authorization studies.
- Plan observational studies and draft protocol synopsis (or protocol concept sheet).
- Lead draft and review observational study protocols analysis plans and study reports to answer methodologic questions of priority to RWE.
- Determine observational study design criteria including source data analytical methods and analysis plans.
- Conduct literature review to support development of study design.
- Perform feasibility analysis for studies and 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.
- Conduct observational studies both primary data collection and secondary data use studies.
- Oversee study data analysis according to observational methods.
- Review analysis outputs for quality including study analysis ad hoc analysis analysis to support conference or publications.
- Conduct quality review of all deliverables to ensure data and results are accurate.
- Work with scientific and operational stakeholders to identify and resolve issues.
- Collaborate with study teams vendors and other stakeholders to advance study and analysis deliverables.
- Work with relevant stakeholders to meet study milestones and timelines.
- Participate in program or study planning meetings.
- Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks.
- Contribute to ongoing improvement of programming processes and methodology.
- Perform other related duties as required by the Department.
- 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.
Minimum Requirements
- PhD in Epidemiology or related field with a minimum of four (4) years of relevant post-doctoral experience preferably in pharmaceutical industry biotechnology or consulting environment. Masters degree in epidemiology or relevant scientific field plus 7-9 years of experience in lieu of PhD may be acceptable.
- 7 10 years industry experience as an epidemiologist is preferred.
- Oncology RWD/RWE Study Experience specifically in commercial oncology EHR and claims databases.
- 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.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $110500.00 - $276100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
Senior IC