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Biostatistics is the area of statistics that covers and provides the specialized methodology for collecting and analyzing biomedical and healthcare data. In general, the purpose of using biostatistics is to gather data that can be used to provide honest information about unanswered biomedical questions. In particular, biostatistics is used to differentiate between chance occurrences and possible causal associations, for identifying and estimating the effects of risk factors, for identifying the causes or predispositions related to diseases, for estimating the incidence and prevalence of diseases, for testing and evaluating the efficacy of new drugs or treatments, and for exploring and describing the well being of the general public.

A biostatistician is a scientist trained in statistics who also works in disciplines related to medical research and public health, who designs data collection procedures, analyzes data, interprets data analyses, and helps summarize the results of the studies. Biostatisticians may also develop and apply new statistical methodology required for analyzing biomedical data. Generally, a biostatistician works with a team of medical researchers and is responsible for designing the statistical protocol to be used in a study.

Biostatisticians commonly participate in research in the biomedical fields such as epidemiology, toxicology, nutrition, and genetics, and also often work for pharmaceutical companies. In fact, biostatisticians are widely employed in government agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). Biostatisticians are also employed by pharmaceutical companies, medical research units such as the MAYO Clinic and Fred Hutchison Cancer Research Center, Sloan-Kettering Institute, and many research universities. Furthermore, some biostatisticians serve on the editorial boards of medical journals and many serve as referees for biomedical journal articles in an effort to ensure the quality and integrity of data-based biomedical results that are published.