Senior SDTM Programmer

1 week ago


Bengaluru, Karnataka, India ICON plc Full time ₹ 5,00,000 - ₹ 15,00,000 per year

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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