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 supervision of senior staff. Design methodologically sound studies to meet project objectives and stakeholder requirements . Conduct and review analyses, evaluate and provide reporting of studies. .

Essential Functions

• Leads 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.
• Support senior staff on specific research initiatives as needed.
• Serves as project lead on smaller projects or in support of project lead on larger client facing or internal projects.
• Authors of 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 with input and oversight of senior staff.
• Reviews and provides relevant epidemiological research input to statistical analysis plans and analysis output.
• Reviews and provides epidemiology input for tasks including CRF/eCRF development, form previews and other ad hoc project tasks

Qualifications

• Master's Degree Graduate education in epidemiology, pharmacoepidemiology, public health with concentration in epidemiology, pharmacy with concentration in epidemiology or relevant scientific field and 5 years relevant experience Req Or
• Ph.D. with 2 years relevant experience Pref
• Sound methodological training in epidemiology, pharmacoepidemiology, public health with concentration in epidemiology, pharmacy with concentration in epidemiology or related area relevant to observational health research.
• Ability to design, plan and conduct observational studies of comparative effectiveness and safety.
• Must be proficient in Word, Excel, PowerPoint and Edge. Ability to read outputs from SAS, R or other programming languages.