{"id":6897,"date":"2026-01-13T09:36:00","date_gmt":"2026-01-13T08:36:00","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&p=6897"},"modified":"2026-07-13T19:08:51","modified_gmt":"2026-07-13T17:08:51","slug":"biostatistics","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/biostatistics\/","title":{"rendered":"Biostatistics"},"content":{"rendered":"

Biostatistics is the application of statistical methods to questions in medicine and forms the methodological backbone of all clinical research. Its role begins with study planning (sample size calculation) and extends through the design of the Statistical Analysis Plan (SAP) to the final interpretation of the data. In accordance with the ICH guideline E9, biostatistical principles must be strictly adhered to in order to ensure the integrity of the results.
In a CRO, biostatisticians work closely with data management to ensure that the collected data can be converted into formats such as CDISC ADaM, which are required for regulatory submissions. They perform interim analyses, assess the statistical significance of endpoints, and produce the tables, figures and listings (TLFs) for the Clinical Study Report (CSR).
Modern biostatistics uses innovative approaches such as Bayesian methods, adaptive study designs, and the integration of real-world evidence. The ability to develop complex data models (e.g. for survival analyses) is a key differentiating feature of a CRO and indispensable for a successful benefit-risk assessment and the defence of study results before regulatory authorities.<\/p>\n

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Biostatistics is the application of statistical methods to questions in medicine and forms the methodological backbone of all clinical research. Its role begins with study planning (sample size calculation) and extends through the design of the Statistical Analysis Plan (SAP) to the final interpretation of the data. In accordance with the ICH guideline E9, biostatistical […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6897","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6897\/revisions"}],"predecessor-version":[{"id":6898,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6897\/revisions\/6898"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6897"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}