Data Standards EngineerVirtualVocations • South Bend, Indiana, United States
Data Standards Engineer
VirtualVocations • South Bend, Indiana, United States
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A company is looking for a Data Standards Engineer to lead standardization efforts in ADaM programming and departmental initiatives in a remote setting.
Key Responsibilities
Serve as the Subject Matter Expert for ADaM Oncology standards and oversee the development of mapping specifications
Provide expert guidance to Statistical Programmers on study-level ADaM mappings and act as the primary contact for Oncology-related queries
Conduct impact assessments of changes to collection forms and lead the ADaM Oncology Working Group
Required Qualifications
3 years of related experience with a M.S. in Computer Science, Biostatistics, or similar, or 5 years of related experience with a B.S. in the same fields
Strong knowledge of SDTM and ADaM standards
Familiarity with FDA, PMDA, and EMA submission requirements
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