Epidemiologist

A global leader in the healthcare industry, this organization specializes in leveraging data, technology, advanced analytics, and expertise to drive progress in healthcare and human health. They offer solutions that enhance patient outcomes, improve clinical trial efficiency, and optimize commercial performance. Their services include data management, consulting, and technology solutions tailored to the needs of healthcare providers, pharmaceutical companies, and other stakeholders in the healthcare ecosystem.

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 (e.g., regulatory, payers, etc.). Provide input on the data elements and design of eCRFs (when applicable) as well as input 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 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 (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.
• 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 oversee or conduct statistical analysis as needed.
• May contribute to the development of high quality proposals for new projects.
• May contribute to the development of best practices in epidemiology and observational research and other internal initiatives.

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.
• Ph.D. with 2 years relevant experience.
• 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.
• 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.
• 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.