Programmer, SDTM & Programming
Job ID 50470
Experience 2 Years
• Assist in the development, validation, and review of study & standard programs/macros (Including SAS, CQL, PL/SQL, SPOTFIRE, R-
Programming, Python) that support standard and study-level conversion of clinical trial data.
• Be able to develop and validate aCRF, SDTM mapping, define.xml, Pinnacle 21, SDRG (Study Data Reviewers Guide), data Listings
and checks for various standard or specific studies.
• Responsible for requirement gathering, development of specifications, Validation plans and performing end to end validation of
• May assist the programmers in troubleshooting and debugging of standard and study programs/macros.
• Applies knowledge on defensive programming techniques.
• Applies knowledge on regulatory submissions.
• Hands-on knowledge on programming data conversions.
• Provide support for end-to-end study activities and ensure deliverables are met on time.
• Establish and maintain effective working relationships with partners and stakeholders.
• May need to understand the industry standards and updates and be able to apply them.
• Adhere to the relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements and industry
best practices and ensure compliance in all activities undertaken.