Senior Statistical Programmer

IQVIA · India

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
• .Strong 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

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