 
						Senior SDTM Programmer
1 week ago
Shift: 2pm - 11pm IST (Remote)
Role & responsibilities
- Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
- Program reports and listings as requested by project team members for ongoing studies.
- Develop transfer specifications with vendors for external data sources.
- Perform consistency checks on data transferred between client and external parties to ensure completeness and accuracy of data contained transfers.
- Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format
- Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
- Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency
MUST HAVE Skillsets:
- Bachelors degree OR certification.
- Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry.
- Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT
- , SDRG development and SDTM data transfer operations on clinical studies.
- Understanding of regulatory requirements relevant to submissions.
- Knowledge of clinical trial study design and electronic data submission requirements.
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