FHIR and CDISC Specialist

Key Role:
Support data standards, including HL7 and Fast Healthcare Interoperability Resources (FHIR) efforts for a rapidly growing segment of federal health business in clinical data, bioinformatics, and regulatory review processes, tools, and systems. Support client engagements, including marketing and proposal development, delivery, and execution, and work with a team of regulatory scientists, clinical data specialists, and data scientists. Support FDA clinical data and regulatory review leaders by providing tools and services to assess and analyze clinical study data and help medical reviewers leverage technology with analytical tools, processes, and approaches that facilitate regulatory review and enhance data standards management and computing capabilities to support effective and efficient regulatory decision-making. Execute data standards projects, synthesize and analyze complex data, and work with the team to develop high-quality deliverables and actionable recommendations in a fast-paced environment.

Basic Qualifications:

  • 2 years of experience with HL7, FHIR standards, CDISC, emerging system integration technologies, analysis, design, programming, training, and implementation planning
  • 2 years of experience with developing HL7 artifacts, including resources and profile definitions, following the development guidelines, policies, and procedures as defined by HL7 for FHIR development
  • Knowledge of HL7 versions, including HL7 Common Document Architecture (CDA)
  • Ability to obtain a security clearance
  • BA or BS degree

Additional Qualifications:

  • Experience with Clinical Data Interchange Standards Consortium (CDISC), SDTM, TAUGs, ADaM, and analysis data standards
  • Experience in working with the federal government, including the FDA
  • Experience with health or bio-informatics software tools, including SAS, R, JMP, or JMP Clinical
  • Knowledge of CDISC study data standards, DataFit, JReview, JMP, and clinical trial terminologies, such as base SAS programming
  • Knowledge of drug development and regulatory pathways

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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