Training and education:
Researchers need basic biostatistical knowledge to plan meaningful studies. They also require legally certified courses, such as Biostatistics modules, for their work as principal investigator.
Planning of the study design:
Depending on the trial, designs need to be developed by a biostatistician in consultation with the investigator to answer the study question adequately.
Calculation of the number of cases:
Depending on the design, the study requires sopisticated calculations with special biostatistical computer programms to determine the optimal sample size.
Creation of statistical analysis plans:
In the context of evidence-based medicine each study requires a statistical analysis plan to document the results of the study consistently and transparently.
The biostatistical calculations should be performed by a qualified statistician or mathematician, by using validated and accepted biostatistical programs.
Biostatistical reports for the researchers and authorities:
Upon completion, each study requires a biostatistical report, which forms the basis of the published results and the mandatory report for the authorities.
Application for fundraising and ethics committees:
In the process of fundraising and for each ethics application, a description of the biostatistical concept is needed. Public funding donors also demand a signature from a certified statistician/mathematician.
Implementation of the DSMB:
According to current German guidelines, at least one biostatistician has to attend the DSMB to calculate, display and rate the required security parameters.
Review process of journals:
In order to answer specific biostatistical questions in the review process of journals, a biostatistician must be on hand.
To represent complex research findings as numbers and graphs, a biostatistician is required as a part of the team, to act as an evaluator and co-author for the publication.