BryceTech
aerospace, biosecurity, and defense
RegulatoryDataTechnicalAdvisor
Neural analysis suggests this role is
optimal for mid candidates.
“Regulatory Data Technical Advisor at BryceTech. Skills: CDISC SEND, SENDIG-AR, regulatory data standards, data quality, data governance. Serve as technical SME for CDISC SEND and SENDIG-AR (2019). Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets”
Industry & Context.
troubleshoot issues for dataset packages; data acceptance and rejection criteria establishment
possibility to assist in remote and/or on-site data audits of BARDA contracted research
What They're Looking For.
Must Have
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, Direct SEND implementation experience, Client-focused approach, Ability to prioritize workload in a hybrid/remote work environment
Nice to Have
Extensive knowledge of FDA/ICH guidelines and CDISC data standards, Experience with applying statistical and epidemiologic methods to nonclinical datasets, including survival analysis and cross-study integration, Quality control and quality assurance experience with nonclinical datasets
What You'll Do.
Serve as technical SME for CDISC SEND and SENDIG-AR (2019), 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, Establish data acceptance and rejection criteria aligned with regulatory expectations, Contribute to DCC end user interface testing and acceptance criteria, Assist in developing end user training and implementation plans, Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.
600 and 601.
90), Assist other contractors by translating regulatory requirements into operational data standards specifications, Perform quality control of dataset packages, Integrate knowledge of nonclinical study conduct to assure correct dataset output, Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.
SEND] review, study report QC, and other reviews, as required, Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts, Learn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted research, Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs), Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs), Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose, Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors, Advise CRO contractors on data delivery and format requirements, Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards, Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs.
How You'll Work.
Team & Collaboration
Communicate findings to team members and management; Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages; Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs); Act as the primary data management contact for BARDA ARD/nonclinical PCTs; Coordinate with PCTs to determine intended use for data derived from contract(s); Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans; Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs
Communication Scope
Communicate findings to team members and management; Assist other contractors by translating regulatory requirements into operational data standards specifications; Advise CRO contractors on data delivery and format requirements
Process & Methodology
data management plans, quality assurance project plans
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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