This certification is aimed directly at SAS programmers in the pharmaceutical industry. Currently there are two versions offered: One, accelerated, version for those with the base programmer credentials and one for those without. The accelerated version contains 71 questions and you have to pass 70% of them in two hours. The full length clinical trials programmer certification has 99 questions and 70% must be achieved in three hours to pass and you do not need to have the base programmer credential.
We will focus on the non-accelerated version so that it will prepare us for both types of exams. The non-accelerated version covers the following topics:
• Clinical trials process, SAP, principles of 21 CFR Part 11, Good Clinical Practices
• Clinical trials data structures,
• Import and export clinical trials data
• Manage clinical trials data
• Transform clinical trials data, change from baseline, LOCF
• Apply statistical procedures for clinical trials
• Macro programming for clinical trials
• Report clinical trials results, PROC REPORT and ODS
• Validate clinical trial data reporting
As much as a SAS programmer in the pharmaceutical industry needs to know DATA step, PROC SQL, the SAS macro language and at least a couple of useful PROCs, understanding of the data, the regulations, documentation and, a basic understanding of statistics is just as important.
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