The statistician helps express the clinical questions in measurable, statistically tractible formulations.
The study design must be chosen to allow the collection of analysable data.
Each measure must be justified by the corresponding sample size calculation.
The statistician formulates the statistical language for the protocol.
Most studies are randomized. The statistician either performs the randomization or validates it, assuring that the unknown effects of the substances tested are equally distributed among the treatment groups and that observed differences are due to the treatment effect.
The statistician plays a key role in the management of protocol deviations, including:
Answering questions about deviations during the study to ensure that the data collected are unbiased.
Collecting and evaluation the seriousness of deviations before the database is locked.
Then, of course, the appropriate statistical methods must be used to analyse the data collected.
The results of the study must then be interpreted in understandable, clinical summaries.
Of course, the results must be published. And don't forget answering health authority questions.
And the statistical interpretation must be integrated into the clinical study report.