Senior Data Standards and Delivery Lead
1 month ago
Key Responsibilities:
• Develop, validate, and review study and standard programs/macros to support conversion of clinical trial data, including SAS, CQL, PL/SQL, SPOTFIRE, R-Programming, and Python.
• Review, develop, and validate SDTM mapping, aCRF, SDRG, Pinnacle 21, define.xml, and data listings for various standard or specific studies.
• Lead requirement gathering, specification development, validation planning, and end-to-end validation of Standard/Study macros.
• Implement defensive programming techniques for macro/program/tool development lifecycle management.
• Project manage end-to-end study delivery and ensure timely completion of deliverables.
• Handle end-to-end studies from CDM to submission.
• Support programmers in troubleshooting and debugging complex standard and study programs/macros.
• Act as a technical owner and/or reviewer/approver for tools and programs developed in the group.
• Oversee and coordinate a group of programmers for complex programs/tools in a matrix setting.
• Establish and maintain effective working relationships with partners and stakeholders, assisting them through progress and challenges with deliverables.
• Adhere to relevant departmental SOPs, corporate policies, regulatory requirements, and industry best practices.
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Data Standards and SDTM Delivery Team Lead
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Bengaluru, Karnataka, India ScaleneWorks Full timeAbout the RoleScaleneWorks seeks an experienced Data Standards and SDTM Delivery Team Lead to join our team. As a key member of our organization, you will be responsible for leading the development, validation, and review of study and standard programs/macros that support standard and study-level conversion of clinical trial data.
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