Job Overview
Manage an assigned team of epidemiology staff who lead or support sponsored research programs to ensure quality, time and budget deliverables are met. 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 supervise 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
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems, and helping the department achieve its quality and finance goals.
• 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 or in support of project lead on 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
• Reviews and provides relevant epidemiological 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 as warranted, with senior staff involvement as needed.
• Identifies client-related, budget-related and internal issues that may require attention or escalation.
• Use best efforts to complete work with 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 with input and oversight from senior staff as needed.
• 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
• 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
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• 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.
• 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.
• Ability and interest in managing and supporting the development of one or more junior team members.
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 https://jobs.iqvia.com