Job Requirements
Remote
Public Trust Polygraph not specified
Senior Level Career (10+ yrs experience)
Salary not specified
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Job Description
BARDA / Nonclinical Data Standards and Analytics Program/Technical Advisor (Mid-level)
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 and 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 within some travel (25% or less) that requires the ability to obtain Public Trust; Tier 2 clearance. Preference for 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
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 and 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 within some travel (25% or less) that requires the ability to obtain Public Trust; Tier 2 clearance. Preference for 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
group id: 10439009