Programmer II/Sr. Programmer
Posted on 11/30/2023
United States
Experience Level
Desired Skills
Software Engineering
Biology & Biotech
  • MS (or equivalent degree) with 3+ years or BS with 5+ years of relevant work experience in clinical research as a SAS programmer for phase I-IV clinical trials in a Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
  • Highly competent with SAS language and procedures commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH. Familiarity or experience with R Software is a plus
  • Well-organized with the ability to multitask and manage shifting priorities in a dynamic, cross-functional teamwork environment
  • Excellent collaboration skills with attention to detail and willingness to help other study programmers when the need arises
  • Demonstrated excellent analytical, technical, and computer skills
  • Excellent verbal and written communication skills are required
  • Primary SAS production and validation programmer for Phase I and IV studies
  • Primary responsibilities included CSR programming, review of standard study documents, ensure study and database integrity
  • Following programming standards and ensuring compliance with SOPs to produce high-quality and timely deliverables
  • Complete project deliverables on time and with utmost quality, assist other programmers in meeting study deadlines
  • Develop SAS programs to create SDTM/ADaM datasets and ensure they pass Pinnacle 21 checks
  • Ability to generate and review the TFLs, XPT files, define.xml, cSDRG, ADRG, and aCRF for submission to various regulatory agencies
  • Handle multiple project queries and/or adhoc requests efficiently and meet various project deadlines
  • Seek clarification with Study Statistician on planned study analysis and develop adam datasets and TFLs as per the study requirements
  • Collaborate with DM to review vendor DTS and check the vendor data transfers
  • Developed standard macros to avoid repetitive tasks and ensure uniformity in reporting
Desired Qualifications
  • Familiarity or experience with R Software