Regulatory Data Technical Advisor

Company DescriptionBryceTech 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.

Job DescriptionBryceTech 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 and governance of DCC datasets structured according to and extensive professional experience in CDISC Standard for the Exchange of Nonclinical Data (SEND), with emphasis on the SEND Implementation Guide - Animal Rule (SENDIG-AR), 2019, and alignment with FDA Guidance 'Product Development Under the Animal Rule.

The person in this role will:

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 datasetsSupport design and implementation of DCC data architecture and metadata governance frameworksEstablish data acceptance and rejection criteria aligned with regulatory expectationsContribute to DCC end user interface testing and acceptance criteriaAssist in developing end user training and implementation plansEnsure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90)Assist other contractors by translating regulatory requirements into operational data standards specificationsPerform quality control of dataset packagesIntegrate knowledge of nonclinical study conduct to assure correct dataset outputKnowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packagesCommunicate findings to team members and managementObtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as requiredAdhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC effortsLearn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted researchProvide 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 purposeCoordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractorsDevelop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timelinessAdvise CRO contractors on data delivery and format requirementsReceive and review raw data from CRO contractors for completeness and quality according to established quality control standardsCoordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs 

QualificationsRequired Qualifications:

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 analyticsDirect SEND implementation experienceClient-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment

Preferred Qualifications:

Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferredExperience with applying statistical and epidemiologic methods to nonclinical datasets, including survival analysis and cross-study integration a plusQuality control and quality assurance experience with nonclinical datasets is a plusAdditional InformationBryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

All your information will be kept confidential according to EEO guidelines.