Biostatisticians in clinical trial management have a long to-do list. They advise on study design, calculate the right sample size, and ensure that the enrolled patients are correctly randomized. They help define endpoints, provide definitions for data analysis and create tables and figures for the clinical study report.
Another essential task for biostatisticians is to support the randomization and stratification of study participants to avoid bias in the resulting data. Bias can occur when clinical trial results are affected by factors not related to the treatment being tested. Stratification of patient subgroups – those receiving either the treatment or placebo – ensures that the subgroups are sufficiently homogeneous to be comparable. Especially with sites in different countries or environments, it is essential to ensure that subgroups should contain a representative partition of the local population.
