Health Informatics Consultant, Senior

Key Role:

Apply expertise in problem solving to develop ing solutions to operational, strategic, and data challenges for federal public health agencies. Use data resources and bioinformatics software to develop specialized databases and analytical tools. Recommend enhancements to analytical, processing, and statistical software, test improvements to bioinformatics tools, and support provision of access to relevant data and enhanced analytical, visualization, and other computational tools and techniques. Leverage expertise across a wide variety of areas, as applied to the regulatory review of medical products, including information retrieval technology, data storage, data mining, and training. Provide direction to staff in the development of advanced information technology solutions to integrate clinical and nonclinical data into regulatory decision making and communicate practical solutions, including emerging technologies, to clients in the form of data-driven presentations, briefings, and reports. Support business development objectives by contributing to proposals and marketing efforts.

Basic Qualifications:

-6+ years of experience with bioinformatics or medical product review or development 

-3+ years of experience with working for one or more of the following: the FDA, health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, analytics, or consulting, or strategy or management consulting

-3+ years of experience with health or bio-informatics software tools, including SAS, R, JMP, or JMP Clinical

-Experience with Clinical Data Interchange Standards Consortium (CDISC) data standards, including SDTM and SEND

-Experience with clinical and nonclinical data management and analysis

-Knowledge of medical product development and regulatory pathways

-Ability to work in a team-based or project environment

-Ability to lead projects or tasks

-BA or BS degree in Life Sciences, Health/Bio-informatics, Epidemiology, Engineering, Mathematics, or Statistics

Additional Qualifications:

-Experience with knowledge management systems

-Experience with business process reengineering

-Possession of excellent analytical skills

-Possession of excellent oral and written communication skills

-MPH, MBA, or MA or MS degree in Life Sciences, Health/Bio-informatics, Epidemiology, Engineering, Mathematics, Statistics, or Health-related field preferred; PhD degree in Life Sciences, Health/Bio-informatics, Epidemiology, Engineering, Mathematics, Statistics, or Health-related field a plus

-Regulatory Affairs Certification (RAC)

-Project Management Professional (PMP) Certification

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