Clinical Trials Programmer Lead

7 days ago


Austin, Texas, United States Della Infotech Full time
Clinical Trials Programmer Lead Position

At Della Infotech, we are seeking a skilled Clinical Trials Programmer Lead to join our team. The successful candidate will be responsible for leading programming projects, ensuring high-quality deliverables, and collaborating with cross-functional teams.

Key Responsibilities:
  • Lead programming projects, including planning, execution, and delivery
  • Collaborate with Clinical Data Managers, Statistical Programmers, and Biostatisticians on project tasks and requirements
  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells, and other specifications
  • Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high-complexity studies
  • Manage study documentation flow as per Worldwide SOP and other procedural documentation

Requirements:
  • 8+ years of SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry
  • Excellent communication skills and ability to communicate with executives and other analysts
  • Proficiency in Base SAS programming (DATA step), SQL programming, and SAS Macro language
  • Familiarity with programming to generate summary statistics and complex statistical methods
  • CDISC data models and knowledge of CDISC standards


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