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 (eg, 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 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