Beyond tables and P-values: Enhancing the role of the clinical trial team statistician
*Sonia Davis, Quintiles 

Keywords: team statistician, clinical trial

Team statisticians are involved in a clinical trial from protocol design to approval. Due to our broad focus and analytical skills, we are uniquely positioned as problem-solvers throughout a trial. To enhance our contributions, we must be informed, engaged, and proactive.

We need full trial training at the investigators meeting. In turn, we should present at the CRA training on key data items and important design issues. We can help plan efficient site monitoring and we can predict event rates for event-based trials. As unblinded statisticians, we can provide substantial contributions to a DMC by offering explanations, data interpretation, and solutions to address DMC queries. An informed and engaged team statistician will be sought out by team leaders for guidance on a variety of issues. Furthermore, a proactive team statistician can identify some issues before they develop.