ADaM Data Standards Engineer

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