Key Role:

Support and develop a rapidly growing segment of our federal health business in clinical data, bioinformatics, and regulatory review processes, tools, and systems. Work 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 in providing tools and services to assess and analyze clinical study data. 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. Coordinate with program managers to develop new business opportunities and author the technical approach for proposals.

Basic Qualifications:

• Experience in developing HL7 artifacts, including resources and profile definitions, following the development guidelines, policies, and procedures as defined by HL7 for FHIR development

• Experience with HL7 Fast Healthcare Interoperability Resources (FHIR) standards, emerging system integration technologies, analysis, design, programming, training, and implementation planning

• Experience in working with Federal Government specifically FDA

• Knowledge of HL7 versions including HL7 Common Document Architecture (CDA)

• Knowledge of the full range of Structured Product Labeling (SPL) use cases, including submission guidelines or information content

• Knowledge of CDISC study data standards, DataFit, JReview, JMP, and clinical trial terminologies

• Knowledge of drug development and regulatory pathways

• 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 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, including base SAS programming

• Knowledge of FDA Office of Biostatistics, OND, and OSP

Clearance:

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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