Senior Data Standards and Delivery Lead

1 month ago


Bengaluru, Karnataka, India ScaleneWorks Full time

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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