Why do you need a biostatistician?

Antonia Zapf,Meinhard Kieser,Geraldine Rauch

doi:10.1186/s12874-020-0916-4

Abstract

The quality of medical research importantly depends, among other aspects, on a valid statistical planning of the study, analysis of the data, and reporting of the results, which is usually guaranteed by a biostatistician. However, there are several related professions next to the biostatistician, for example epidemiologists, medical informaticians and bioinformaticians. For medical experts, it is often not clear what the differences between these professions are and how the specific role of a biostatistician can be described. For physicians involved in medical research, this is problematic because false expectations often lead to frustration on both sides. Therefore, the aim of this article is to outline the tasks and responsibilities of biostatisticians in clinical trials as well as in other fields of application in medical research.

Highlights

Tasks and responsibilities of biostatisticians There are many medical areas where biostatisticians can contribute to the general research progress
We consider in the following the important application fields of clinical trials, systematic reviews and meta-analysis, observational and complex interventional studies, and statistical genetics to highlight the tasks and responsibilities of biostatisticians working in these areas
Biostatisticians working in the area of clinical trials The tasks of biostatisticians in clinical trials are not limited to the analysis of the data, but there are many more responsibilities

Summary

Introduction

Tasks and responsibilities of biostatisticians There are many medical areas where biostatisticians can contribute to the general research progress. According to Lewis et al (1996), statistical considerations are relevant for the analysis of data and for the design of the trial [7] This is not a personal view, but general consensus. The corresponding guideline E6 from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) explicitly states that statistical expertise should be utilized throughout all stages [8] In there, it is stated in Section 5.4.1: ‘The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs [case report forms, AZ] and planning the analyses to analyzing and preparing interim and final clinical trial reports.’.

Objectives

Discussion

Conclusion