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Sdtm Programmer

4 weeks ago

India Cytel, India Full time

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

**SAS Programmer for SDTM Datasets QC/Validation Programming**
- Designs and codes complex SAS programs for performing QC/validation of the SDTM Datasets by creating CDSIC SDTM datasets using raw datasets and then comparing them with the SDTM datasets provided to perform QC for assigned project(s), consistently meeting objectives of the project. Performs quality control checks of advanced SAS code and any output produced by other Programmers.
- Responsible for quality and timely delivery of SDTM QC artifacts
- Reviews the Study EDC specification and Study SDTM Mapping specification and ensures all collected study data (including external) is mapped appropriately in the target SDTM model
- Maintains high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and other Quality tools

**Experience Requirements**:

- B.S. (or equivalent degree) and 5+ years of relevant work experience
- Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
- Demonstrates advanced knowledge of electronic submissions and CDlSC SDTM Demonstrates in-depth knowledge of FDA/ICH guidelines, industry/technology standard practices, and good programming practices
- Demonstrates in-depth understanding of regulatory, industry, and technology standards and requirements
- Demonstrates in-depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs
- Displays good organizational skills, problem-solving abilities, time management skills, and initiative
- Communicates effectively in verbal presentations and written technical reports to all stakeholders

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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