Clinical Programmer Specialist

6 days ago


Columbia, South Carolina, United States GForce Life Sciences Full time

Job Summary

GForce Life Sciences is seeking a highly skilled Clinical Programmer to join our team. As a Clinical Programmer, you will be responsible for assigned statistical programming activities on a collaboration and license agreement for Europe, China, and other territories.

Key Responsibilities

  • Develop and validate programs that generate SDTM and analysis datasets based on ADaM specifications
  • Prepare and quality control ADaM datasets documentation, including Reviewer's Guide and analysis metadata report
  • Develop and validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP)
  • Perform quality control on final reports
  • Provide quality control and validation reports
  • Support the development of technical programming specifications for ADaM standards
  • Communicate with programming and statistics leads, data managers, and other team members
  • Provide project progress updates on programming activities

Requirements

  • Bachelor's degree in Statistics, Mathematics, or Computer Science or a related field
  • 8+ years of SAS programming and application development experience in Biotechnology/Pharmaceutical/CRO
  • Industry experience as a clinical trial SAS programmer; SAS experience in drug development in CRO or pharma/biotech company
  • Knowledgeable in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS
  • Familiar with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Proficiency in a LINUX environment
  • Experience with all clinical phases I, II, III, and IV of trials
  • NDA submission experience

Benefits

  • 12-month contract
  • Remote/home-based
  • Employer contributed health benefits (medical, dental, vision)


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