Pretoria Remote (Global)

PSI CRO is hiring a SAS Developer (SDTM)

About the Role

Role Overview

As a SAS Developer (officially titled Database Developer), you will play a key role in shaping clinical data management processes within a global team. Your work will center on designing and programming clinical databases, ensuring data integrity, and delivering high-quality outputs aligned with regulatory standards.

Key Responsibilities

  • Serve as a technical contact between data management and statistical teams for database programming and deliverable development
  • Review and assess clinical database (EDC) structure and requirements
  • Contribute to data validation planning and implement automated validation checks
  • Develop listings and reports used in data collection, monitoring, and review during clinical trials
  • Create patient-level profiles through programming
  • Support the creation of SDTM deliverables including define.xml, annotated CRFs, and reviewer’s guides
  • Program data transformations from raw sources into CDISC-compliant formats
  • Verify clinical data accuracy against SDTM specifications
  • Manage the transfer of final databases to clients using secure electronic methods
  • Coordinate with external vendors and sponsors on data transfer protocols
  • Receive and validate incoming electronic data submissions

Technical Expertise

Proficiency in SAS programming is essential, along with hands-on experience in SDTM and CDISC standards. Familiarity with EDC systems, define.xml, annotated CRFs, data validation logic, and clinical database design is required to succeed in this role.

Required Skills
SASSDTMCDISCdefine.xmlEDCannotated CRFclinical database programmingdata validationelectronic data transfer SASSDTMCDISCEDCdefine.xmlannotated CRFdata validation proceduresclinical database programming
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About company
PSI CRO

PSI is a leading full-service global Contract Research Organization (CRO). The company specializes in delivering pivotal Phase 2 and Phase 3 clinical trials on time and on budget, with predictable patient enrollment across multiple therapeutic areas.

PSI focuses on a wide range of therapeutic areas including Oncology, Gastroenterology (GI), Hematology, Cell and Gene Therapy, Neurology, Infectious Diseases, Radiopharmaceuticals, and Respiratory diseases, among others.

The company leverages advanced platforms like Visional for clinical trial feasibility analysis and Synetic for site intelligence and study acceleration, aiming to protect trials from delays and budget overruns through data-driven solutions.

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Job Details
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Posted 22 days ago