Clinical BioStatistician/Programmer: A Day In The Life

By Justin Sjogren, MS, Clinical BioStatistician/Programmer

Statisticians play an important role in many phases of the clinical trial process, beginning at the design stage and progressing through the final analysis. Statisticians keep the big picture in mind and key strengths include their ability to ask good questions, or ask why a particular decision was made and how best to ensure that each question is worthwhile and useful. They provide input early on in trial development about things such as the type of trial design, randomization considerations, and sample size calculations, which identify the number of subjects needed for a successful trial. All these items help to save the sponsor in time and cost.

Another key responsibility of the statistician is to write the Statistical Analysis Plan (SAP). This regulatory document tells specifically how the analyses will be performed and what will be reported in the final tables. This is where the statistician can think more deeply about how to answer the research question through the appropriate analyses.

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