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.

Biostatistical calculations:

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.

Final publication:

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.