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 .
Solid 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 Statistical Programmer (India)
🏢 Iqvia
📍 India