BryceTech
Healthcare
RegulatoryDataTechnicalAdvisor
Neural analysis suggests this role is
optimal for mid candidates.
“Regulatory Data Technical Advisor at BryceTech. Skills: CDISC SEND, Regulatory data standards, Data quality. Serve as technical SME. Develop validation criteria”
Industry & Context.
Troubleshoot issues
What They're Looking For.
Must Have
Advanced degree in biological/chemical sciences, Minimum eight (8) years relevant industry/postdoctoral experience, Direct SEND implementation experience, Client-focused approach, Ability to prioritize workload
Nice to Have
Extensive knowledge of FDA/ICH guidelines, Extensive knowledge of CDISC data standards, Experience applying statistical methods, Experience applying epidemiologic methods, Survival analysis experience, Cross-study integration experience, Quality control experience with nonclinical datasets, Quality assurance experience with nonclinical datasets
What You'll Do.
Serve as technical SME
Develop validation criteria
Develop business rules
Develop quality control procedures
Support design of DCC data architecture
Support implementation of DCC data architecture
Support design of metadata governance frameworks
Support implementation of metadata governance frameworks
Establish data acceptance criteria
Establish data rejection criteria
Contribute to DCC end user interface testing
Contribute to acceptance criteria
Assist in developing end user training
Assist in developing implementation plans
Ensure alignment with Animal Rule regulatory requirements
Assist contractors translating regulatory requirements
Perform quality control of dataset packages
Integrate knowledge of nonclinical study conduct
Assure correct dataset output
Interact with study personnel
Prepare dataset packages
Review dataset packages
Troubleshoot dataset package issues
Communicate findings to team members
Communicate findings to management
Obtain proficiency with DNCD quality control workflows
Review regulatory datasets
Assist in establishment of DNCD SOPs
Assist in refinement of DNCD SOPs
Adhere to business practice documents
Assist in establishment of business practice documents
Assist in refinement of business practice documents
Learn data audit practices
Assist in data audits
Provide technical expertise to project teams
Act as primary data management contact
Coordinate with PCTs to determine intended data use
Establish data management plans
Ensure data are fit for purpose
Coordinate with PCTs to ensure data management plans
Develop PCT relationships
Advise CRO contractors on data delivery requirements
Advise CRO contractors on data format requirements
Receive raw data from CRO contractors
Review raw data for completeness
Review raw data for quality
Coordinate with statisticians for appropriate methods
Coordinate with statisticians for appropriate practices
How You'll Work.
Team & Collaboration
Communicate findings to team; Coordinate with PCTs; Coordinate with statisticians
Communication Scope
Communicate findings
Full Job Description
BryceTech is a trusted leader in complex technology domains, delivering data-driven solutions in aerospace, biosecurity, and defense. 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. BryceTech has been recognized in the Washington Technology Fast 50 ranking of top high-growth small businesses for five consecutive years and received a GovCon Contractor of the Year Award in 2025, underscoring our strong growth, competitive positioning, and excellence in federal contracting. 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. This position will play a key role with a fast-paced ASPR client providing acquisition and contracting support to all areas of Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals conducted by BARDA. These services are critical in support of BARDA’s mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. The ideal candidate is excited to develop, implement, and manage a data quality and compliance management program for contracted nonclinical research across BARDA’s programs and provide subject matter expertise in nonclinical data standards and advanced analytics to support the development and implementation of a Nonclinical Data Coordination Center (DCC) platform tool. This position focuses on implementation a
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