ADaM Data Standards EngineerVirtualVocations • Plano, Texas, United States
ADaM Data Standards Engineer
VirtualVocations • Plano, Texas, United States
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A company is looking for an ADaM Data Standards Engineer (Remote).
Key Responsibilities :
Lead the development and maintenance of ADaM Oncology Mapping Specifications and Implementation Guides
Serve as the primary contact for Statistical Programmers on Oncology studies, providing expert guidance on ADaM mappings
Conduct impact assessments of changes to Oncology collection forms, SDTM updates, and TFL standards
Required Qualifications :
Bachelor's or Master's degree in Biostatistics, Computer Science, or related field
Minimum of 5 years (BS) or 3 years (MS) of experience in statistical programming, with recent solid tumor oncology exposure
Deep understanding of CDISC ADaM and SDTM standards and regulatory requirements (FDA, PMDA, EMA)
Experience with tools / platforms for SDTM and ADaM mapping and e-submission preparation
Ability to work independently and lead cross-functional initiatives
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Data Engineer • Plano, Texas, United States
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