ADaM Standards SME

Location: home-based in the U.S. or Canada

Summary: IQVIVA is hiring a CDISC Standards Expert to be dedicated to a prominent pharmaceutical company, supporting our client's long-term data standards initiatives. We are expanding this well-established team. Act as ADaM Standards SME in development of standards management strategy and ongoing development and maintenance of standards across the Client's portfolio. Previous experience is required with implementing CDISC standards that supports strategies and processes. Ensure this is in alignment with the vision developed by Client's Data Standards Team.

Responsibilities:

• Develop, update, and maintain ADaM standards.
• Review SDTM standards for updates and impacts on current ADaM CORE standards.
• 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, reviews study submission data packages to ensure quality and integrity.
• Works closely with study leads and Data Management on 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.
• Support 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:

• 8+ years of industry experience focusing in such activities as statistical programming or clinical programming.
• Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements is required.
• Bachelor's degree in computer science, math, statistics, biology, pharmacology or related. Working qualifications will be considered in lieu of related education.
• Prior experience with development, updates or maintenance of ADaM data standards.
• Therapeutic experience in Oncology, Virology, Inflammation is preferred.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $119,400.00 - $203,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.