All Times EDT
Keywords: Advisory committee meeting, industry statistician
In the pharmaceutical industry, statisticians play a vital role in many aspects of the preparation and execution for advisory committee meetings (ACMs). The statistical team can provide valuable input into quantitative strategies for addressing potential questions along with insight into issues that may be raised in ACMs. In this presentation, we will review the different aspects of the industry statistical team contributions to ACMs including complex statistical analyses for addressing aspects of the data for the study/studies under review, strategic thinking to help teams to frame arguments for potential questions from the committee, and clear communication of statistical analysis methodology and results to an audience composed of non-statisticians as well as statisticians. Multiple examples of specific statistical team contributions to ACMs will be provided.