Job title: Principal/ Senior statistical programmer Location: Hyderabad(Hybrid)

Experience: 7+ years

About the Role

We are seeking an experienced Principal Data Standards Analys t to provide leadership in clinical data standards, metadata management, and governance. The role will support the implementation and maintenance of industry-standard clinical metadata, ensuring consistency and compliance across clinical studies.
The ideal candidate will have strong expertise in CDISC standards (CDASH, SDTM, Controlled Terminology, and External Data ) and a thorough understanding of end-to-end clinical data processes

- Key Responsibilities

Serve as a subject matter expert for clinical data standards, metadata governance, and CDISC complianc e

- Lead the review and implementation of study-specific metadata, ensuring alignment with organizational standards and regulatory requirements
- Review and oversee study requests related to data collection, external data, controlled terminology, and SDTM standards
- Collaborate with cross-functional teams to develop and maintain metadata specifications and standards




- Facilitate metadata review meetings and provide guidance on best practices for clinical data standards
- Support the development, maintenance, and governance of global and therapeutic area-specific standards
- Monitor regulatory and industry standards updates and drive their adoption across studies
- Contribute to process improvements and standardization initiatives within clinical data management
- Provide mentorship and guidance to study teams on metadata and data standards implementation
- Required Experience

~7+ years of experienc e in the pharmaceutical, biotechnology, or CRO industry with a focus on Clinical Data Standards, Metadata Management, or Clinical Data Managemen t
~ . Robust knowledge of CDISC standard s, including CDASH, SDTM, Controlled Terminology, and External Data model s
~ . Experience with metadata governance, standards implementation, and clinical data lifecycle management
~ . Understanding of regulatory requirements related to clinical data standards

~ .CDISC certification is a plus

📌 Senior SAS Programmer I (Hyderabad)
🏢 Iqvia
📍 Hyderabad