Jobs for BS Biology
IQVIA is hiring for a dedicated role for a prominent pharmaceutical company. This role will involve supporting the company’s long-term standards initiatives. The selected individual will act as an ADaM Standards SME and contribute to the development of a standards management strategy. They will also be responsible for the ongoing development and maintenance of standards across the client’s portfolio. Previous experience in implementing CDISC standards that support strategies and processes is required. The individual will need to ensure alignment with the vision developed by the client’s Data Standards Team. Therapeutic experience in Oncology, Virology, and Inflammation is preferred.
Job Title: ADaM Standards SME
Primary Location: Durham, North Carolina, United States
Additional Locations: Kirkland, Canada, CAN
Employment Type: Full-time
Job ID: R1391556
Location: Home-based in the U.S. or Canada
Responsibilities: Jobs for BS Statistics
- Develop, update, and maintain ADaM standards.
- Review SDTM standards for updates and impacts on current ADaM CORE standards.
- Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements is required.
- Participate in study-specific ADaM submission package reviews across multiple authorities.
- Provides technical and/or operational support in the delivery and application of industry clinical data standards within the statistical programming data flow (i.e., SDTM, ADaM, DEFINE) for clinical studies, drug programs, and/or in support of drug application submissions.
- Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol, analysis, and CDISC compliance requirements.
- Ensures study-level ADaM datasets are in compliance with CDISC and regulatory submission requirements, and reviews study submission data packages to ensure quality and integrity.
- Works closely with study leads and Data Management on the development of data standards to support data collection requirements; including but not limited to specification of Data transfer agreements (DTAs) in alignment with downstream SDTM and other dataset formats, CRF Standard data collection elements, and external data oversight/strategies to ensure downstream compliance for submission.
- Supports in developing, managing, and maintaining libraries of CDISC-related metadata, terminology, and related standards. Provides governance oversight to ensure consistency in metadata use and development.
- Actively monitors for new regulatory requirements related to data standards and/or data submissions; Communicates and provides impact assessment/consultancy to Data Sciences or specific project teams.
Qualifications: Jobs for BS Biology
The expectation for educational qualifications is a Bachelor’s degree in computer science, math, statistics, biology, pharmacology, or related. Relevant working experience will be considered.