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Program/Technical Advisor (Mid-level)

BACKGROUND: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats. BARDA is looking for a Nonclinical Data Standards and Analytics Program/Technical Advisor to support the Division of Nonclinical Development (DNCD), Data Operations Program.

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 an extensive professional experience in CDISC Standard for the Exchange of Nonclinical Data (SEND), with emphasis on SEND Implementation Guide – Animal Rule (SENDIG-AR), 2019, and alignment with FDA Guidance 'Product Development Under the Animal Rule.

This is a full-time, remote position with some travel (25% or less) that requires the ability to obtain Public Trust; Tier 2 clearance.  Preference for the DMV area, but not a requirement

Required 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 analytics

  • Direct SEND implementation experience

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

  • Ability to work well with a multi-disciplinary team of professionals; Flexible attitude with respect to work assignments and new learning

Preferred 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 a plus

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

  • 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

  • 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)

    • 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

    • 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

    • Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

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