Senior Manager I, Clinical Data Standards & Reporting Engineer
Bristol Myers Squibb
Hyderabad, IN, United States
50% onsite
Cdisc standards implementation
Sdtm and adam models
Metadata repository (mdr)
This role is essential to the development and sustainability of Global & TA Clinical Standards that ensure compliant submissions and success of the BMS R&D pipeline
Job Summary
This role is essential to the development and sustainability of Global & TA Clinical Standards that ensure compliant submissions and success of the BMS R&D pipeline.
Serve as the primary point of contact for study teams on the usage and development of BMS standards, guiding interpretation and application for regulatory compliance.
Contribute to the development of global and TA-specific standards aligned with CDISC and internal BMS frameworks, creating and maintaining standard metadata libraries.
Matching Summary
This role is essential to the development and sustainability of Global & TA Clinical Standards that ensure compliant submissions and success of the BMS R&D pipeline.
Skills & Requirements
Must-have
CDISC standards implementation
SDTM and ADaM models
Metadata Repository (MDR)
SAS & R coding systems
Clinical trial data standards
Nice-to-have
High ability to communicate
Team environment collaboration
Strategic initiative participation
New technologies evaluation
Key Requirements
8 to 11 years of relevant industry experience
Bachelor's degree required
Experience with CDISC standards
Experience interpreting Health Authority regulations