(Senior) Epidemiologist, OMOP, Real World Evidence

Job Overview

Work closely with global clients and other functional groups by providing epidemiology leadership for real world studies on the full spectrum of designs and approaches from early clinical development through the post approval stage, which include but are not limited to the natural history of disease, external comparators, and comparative safety and effectiveness of drugs, biologics, and devices, under the supervision of senior staff. Design methodologically sound studies to meet project objectives and stakeholder requirements (e.g., regulators, payers, etc.). Provide input on the data elements and design of eCRFs (when applicable) as well as input into and review of feasibility and data landscaping. Conduct and review analyses, evaluate and provide reporting of studies. Assignments range in complexity from providing input into feasibility to the development of study protocols and clinical study reports, ensuring data quality and scientific rigor across all facets of real world studies. May contribute to new business development (as appropriate) to maintain and strengthen client base.

Essential Functions

• Leads the design and implementation of epidemiology/pharmacoepidemiology methods in real world studies and studies using real world data, including (but not limited to) drug safety and effectiveness studies and other observational or low intervention studies using real world data and/or methodology.
• Supports senior staff on specific research initiatives as needed.
• Serves as project lead or supports the project lead on client facing or internal projects.
• Authors protocols, reports, and other study documents with independent, critical thinking to ensure quality and completeness of output, oversees timeline for deliverables associated with analysis and reporting.
• Reviews and provides relevant epidemiological research input to statistical analysis plans and analysis outputs.
• Reviews and provides epidemiological input for tasks including CRF/eCRF development, form previews and other ad hoc project tasks (e.g., regulatory responses, slide deck development).
• Interacts with clients with senior staff involvement as needed.
• Identifies client-related, budget-related, and internal issues that may require attention or escalation.
• Uses best efforts to complete work within the available budget.
• Contributes to intra- and interdepartmental process improvement to achieve best practices and to support effective delivery and quality of deliverables.
• May generate content and direction for business development proposals on smaller projects with input and oversight from senior staff.
• May represent IQVIA externally through conference presentations.
• May oversee or conduct statistical analysis as needed.
• May contribute to the development of best practices in epidemiology and observational research and other internal initiatives.

Qualifications

• Ph.D. with 2 years of relevant experience preferred.
• Master's degree in epidemiology, pharmacoepidemiology, public health with a concentration in epidemiology; graduate education in pharmacy with a concentration in epidemiology, with a minimum of 5 years of directly relevant experience required.
• Experience in multi-database studies using common data model approaches, including OMOP, required.
• Sound methodological training in epidemiology, pharmacoepidemiology, public health with a concentration in epidemiology, pharmacy with a concentration in epidemiology or related experience relevant to observational health research.
• Ability to design, plan and conduct observational studies of comparative effectiveness and safety.
• Excellent oral and written communication skills. Medical writing experience beneficial.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients in a global and matrixed environment.
• Exceptional attention to detail and the ability to effectively prioritize and manage multiple tasks.
• Ability to work collaboratively with diverse team members.
• Must be proficient in Word, Excel, PowerPoint, and Edge. Ability to read outputs from SAS, R, or other programming languages.
• Must be highly organized and self-motivated with ability to determine and meet objectives.