Regulatory Data Technical Advisor

About the role

The Regulatory Data Technical Advisor will provide 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. The position involves developing, implementing, and managing a data quality and compliance management program for contracted nonclinical research.

Responsibilities

• 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
• Aid 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
• Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages
• Communicate findings to team members and management
• Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. 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)
• Cook up 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
• Cook up with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors
• Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness
• 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
• Cook up with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

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
• Direct SEND implementation experience
• Client-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment

Qualifications

• 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

Benefits

BryceTech 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.