What is an SDTM programmer?

An SDTM Programmer is responsible for converting clinical trial data into standardized Study Data Tabulation Model (SDTM) datasets as per CDISC (Clinical Data Interchange Standards Consortium) guidelines. They ensure that data is structured and formatted correctly for regulatory submissions to agencies like the FDA or EMA. Their work involves writing SAS programs, validating datasets, and collaborating with clinical teams to ensure compliance and accuracy. Strong knowledge of SDTM standards, SAS programming, and clinical trial processes is essential for this role.