Data Standards SME

Role Overview

About Emmes Group

Responsibilities

• Provide guidance on SDTM standards and submission requirements, including annotated CRFs, define.xml or PDF, Reviewer’s Guides, and XPT files.
• Develop SDTM standards for CRF and non-CRF data, controlled terminology, non-CRF mappings, CDASH database builds, and other industry standards.
• Advise Data Management on CRF design, programmed edit checks, and data transfer specifications.
• Provide SDTM mapping specifications and annotated CRF inputs to Statistical Programming teams.
• Develop programming documentation, specifications, and annotations in compliance with SOPs and regulatory guidance.
• Collaborate with clinical research, biostatistics, and data management teams to align study design with CDISC requirements.
• Maintain current CDISC expertise, present at industry forums, provide project updates, and comply with organizational policies.

Required Qualifications

• A bachelor's degree is required; a master's degree or PhD is preferred.
• The role requires 4 to 6 years of Data Standards experience in a pharmaceutical or CRO environment, with the stated threshold varying by degree level.
• Experience is required in CDISC SDTM, controlled terminology, non-CRF mappings, CDASH database builds, SDTM annotations, submission documentation, and clinical data specifications.
• Understanding of GCP principles and FDA, EMA, and ICH regulatory guidance is required.
• Strong analytical, communication, organization, prioritization, problem-solving, decision-making, and time-management skills are required.