ADaM Standards Engineer

Join a Data Standards Team, dedicated to the standards initiatives of a prominent Pharmaceutical company. Expect to work fully within the sponsor environment. This individual will review existing standards and update them/make recommendations to map to new domains. Also, will participate in the Oncology Standards Steering committee and give feedback on new forms and updates to existing forms for Oncology data collection.

• 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.
• Implements standards that supports data standards strategies and processes in alignment with the vision developed by Client's Data Standards Team
• Acts as ADaM SME in development of standards management strategy and ongoing development and maintenance of standards across Client's portfolio (i.e., CRF to Submission, Drug Program level standards).
• Ensures synchronization of Data Collection Standards with ADaM Standards and applicable company tools/system requirements in collaboration with CRF/Non-CRF Data Collection and ADaM Standards SMEs.
• 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/ 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 ADaM 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.

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