Senior statistical programmer

Job title : Principal/ Senior statistical programmer

Location : Hyderabad(Hybrid)

Experience : 7+ years

About the Role

We are seeking an experienced Principal Data Standards Analyst 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 compliance . 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 experience in the pharmaceutical, biotechnology, or CRO industry with a focus on Clinical Data Standards, Metadata Management, or Clinical Data Management . Strong knowledge of CDISC standards, including CDASH, SDTM, Controlled Terminology, and External Data models . 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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