Data Standards Engineer

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