Senior Sdtm Programmer Jobs in Indiana (NOW HIRING)

Senior SDTM Programmers are experienced professionals in clinical data management who specialize in mapping and converting clinical trial data into the Study Data Tabulation Model (SDTM) format according to regulatory requirements. They ensure that data collected during clinical trials is structured, accurate, and compliant with standards set by organizations like the FDA and CDISC. Senior SDTM Programmers often lead programming activities, perform quality control checks, and collaborate with statisticians, data managers, and regulatory teams to prepare submission-ready datasets. Their expertise is vital for successful clinical trial submissions and regulatory approvals.

As a Senior SDTM Programmer, you frequently collaborate with clinical data management teams to ensure data collected from clinical trials is accurately mapped and transformed into SDTM-compliant datasets. This often involves clarifying data specifications, resolving data discrepancies, and aligning on timelines for data delivery. Close communication helps maintain data integrity and compliance with regulatory standards, making teamwork and proactive problem-solving crucial aspects of the role.

To excel as a Senior SDTM Programmer, you need deep expertise in clinical data standards (especially CDISC SDTM), advanced SAS programming skills, and a relevant degree in life sciences, statistics, or computer science. Familiarity with clinical trial data management systems, regulatory submission requirements, and tools like Pinnacle 21 are also crucial. Strong attention to detail, problem-solving abilities, and effective communication skills help ensure data accuracy and smooth collaboration with cross-functional teams. These competencies are essential to deliver high-quality, regulatory-compliant datasets that support successful clinical trial submissions.