Role of Biostatistics and Responsibilities of Biostatistician in Clinical Research

Role of Biostatistics and Responsibilities of Biostatistician in Clinical Research

The data collected on the subject during the progress of clinical trials are interpreted using Biostatistics to draw inferences analyze the structure of the advancements. Biostatistics acts as a bridge between data entry, collection, and reporting it to the sponsors.

There are many questions that are answered through Biostatistics, like, How does a new drug works? What can be the side effects of the drug? How long can a person survive with the drug? What is the reason for a particular disease, so on and so forth? These queries are analyzed and answered with the application of various models and statistical approaches of inferential, probability, and computing mathematics structure. These methods encompass designs of a wide range of biological experiments. 


Biostatistics is mainly used to infer with the health sciences related to various chronic diseases like AIDS, Cancer, Neurological disorders, and Palliative Care. It helps in interpreting the relationship between genetics and the environment. Its services are provided at each stage of the clinical trial viz Research Planning, Data Collection, Data Checking, and Analysis and Final reporting of the trial. It describes the probability of the impact of a certain dosage of the drug on the treatment of a certain disease.

When it comes to working on a large amount of data, the Brain Imaging Genomics technique comes into sight and various behavioral profiles are identified by disentangling the received data and making inferences. From trial data, protocol development to clinical data monitoring and reporting, Biostatistics is involved in every step.


The Biostatistician works closely with the team of Data Managers, Program developers, and Medical Writers and assists them with the latest advancements in the biomedical dataset specifications. They ensure that the pooled data is properly formatted and the statistical part of the study report is undertaken in lieu of the timelines. It is the role of a biostatistician to outline the study endpoints and plan the analysis and hypothesis testing procedures. They are required to define the sample size of the tested subject that highly influences the budget requirements.

 It is often misinterpreted that a biostatistician is required only after the data is collected, to analyze and infer the assumptions and results. But this is not true, from planning to the dissemination of statistical models, a biostatistician actively participates in the assessment. During the initial planning phase, a biostatistician provides a framework for the physician to function accordingly.

Their work starts even before the general study is finalized because their contributions in terms of pointers have an influence on the whole construct of the issue. A biostatistician makes the medical examiners and investigators aware of the potential problems that may arise. Subsequently, primary endpoints to the categorized variables are suggested by them. Before the main data analysis, the interim studies are also planned under the guidance of biostatisticians. They study the detailed protocol plan and prepare a document that describes all the necessary details on safety and behavior. 

Being specialists in data evaluation, we find biostatisticians on deck with 100% involvement in the statistical consultancy, review, and finalization. The preparation of the SAP- Statistical Analysis Plan is solely the responsibility of the biostatistician. 

With their crucial role in each and every step of the clinical trial, it is very important for them to ensure smooth communication between the personnel in order to conduct the hustle-free implementation of the study. With an effective system of plans that are carried out in the most efficient way, the entire affair of the medical research is managed with the utilization of the key expertise of the biostatisticians and their influence on the techniques of Biostatistics.  

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