BryceTech
Regulatory Data Technical Advisor
Washington, DC, United States · Contract
Sponsorship not specifiedDetected 64 days ago
Contract ManagementSystems EngineeringAR/VRPublic HealthFDA RegulatoryMolecular BiologyResearch
About the role
- BryceTech is a trusted leader in complex technology domains, delivering data-driven solutions in aerospace, biosecurity, and defense.
- With a proven track record of winning sought-after contracts, scaling high-performance teams, and executing on critical government missions, BryceTech presents a compelling opportunity for strategic partnerships in the GovCon space.
- BryceTech is currently looking for a Regulatory Datra Technical Advisor.
Responsibilities
- Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets
- Support design and implementation of DCC data architecture and metadata governance frameworks
- Assist in developing end user training and implementation plans
- Perform quality control of dataset packages
- Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts
- Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness
- Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs
- We specialize in systems engineering, advanced analytics, R&D programs, and strategic advisory support.
- Our clients - including NASA, DoD, HHS, DHS, and other civil and national security agencies - rely on us to drive mission success and accelerate innovation.
Requirements
- Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar)
- Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics
- Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required
Nice to have
- Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred
- Experience with applying statistical and epidemiologic methods to nonclinical datasets, including survival analysis and cross-study integration a plus
- Quality control and quality assurance experience with nonclinical datasets is a plus
- All your information will be kept confidential according to EEO guidelines.
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