Biostatistics

The biostatistics team plays a vital role in planning the clinical trial design, sample size, randomization procedures, and statistical analysis. Thus, the biostatistician’s expertise is pivotal in ensuring a robust data analysis and making sure that the clinical study/investigation has sufficient power to answer the primary objective.

Biostatisticians are also crucial in interpreting the data, drawing conclusions, and handling statistical issues such as multiplicity. The biostatistics team documents the statistical methods in the Statistical Analysis Plan (SAP), which describes the analyses in detail including subgroup analyses, how missing data is handled, and how the data will be presented in the final study/investigation report.

Our biostatistics services include:

• Clinical trial design planning and sample size calculations
• Development of the Statistical Analysis Plan (SAP) according to the study/investigation protocol
• Randomization procedures
• Statistical programming for the final analysis, as well as reports for interim analyses, risk-based monitoring, data monitoring committees, and regulatory submissions.
• Biostatistical analysis including all tables, figures and analyses according to the SAP.
• Support with data interpretation and development of the final report and/or interim reports