Statistical Programmer - MDR

Role: Statistical Programmer - MDR (Metadata Repositories)

Location: Pan India

Experience: 5+ years

Key Responsibilities:

1. Gather and analyze business requirements for Clinical Metadata Repository (MDR) initiatives.
2. Collaborate with clinical, data management, and programming teams to define metadata standards.
3. Create and maintain functional documentation, user stories, and acceptance criteria in Jira/Confluence.
4. Map clinical data to CDISC standards (SDTM, ADaM, CDASH, CT).
5. Validate metadata models, schemas, and data mappings for accuracy and consistency.
6. Support regulatory compliance by ensuring metadata aligns with FDA and EMA requirements.
7. Review and provide functional input on technical designs, APIs, and MDR solutions.
8. Coordinate with cross-functional global stakeholders throughout the project lifecycle.
9. Perform metadata quality checks, impact analysis, and support standards up-versioning/data reuse.
10. Assist in UAT, issue resolution, and continuous improvement of enterprise MDR processes.

Interested candidate can share their resume on [email protected]