Table 1.

Responsibilities of the trial statistician in a study life cycle.

Study life cycle	Responsibilities of the trial statistician
Study design	Contributes to the definition of the study objectives and to the selection of the primary and secondary endpoints Proposes one or several statistical designs until final selection Computes the sample size and the study duration For randomized studies, specifies the method and parameters of the randomization procedure Defines accurately the trial endpoints and the methods of assessment Designs the early stopping rules and interim monitoring plan Writes the statistical analysis plan
During the study conduct	Monitors the assumptions underlying the statistical design Interacts with the Independent Data Monitoring Committee, when pre-specified in the study protocol or in case of unanticipated issues Contributes to the amendment of the study protocol in case of major changes to the statistical considerations of the trial
At each interim, final or long-term data analysis	Assesses the quality of the clinical database for the intended analysis, in terms of completeness and consistency Develops the analysis programs to produce the required tables, graphical displays and inferential analyses Writes the statistical analysis report Contributes to the presentation and publication of the study results Submits the final study results to EMA European Clinical Trials Database (EudraCT) and to US ClinicalTrials.gov public websites