Biostatistical Methods in Clinical Trials

Learn the purpose of clinical trials and how biostatistics is applied to the development, analysis and finalization of the clinical trial process. Topics include an overview of ICH/FDA statistical regulations, planning and writing statistical sections of the protocol, developing and writing the Statistical Analysis Plan, analyzing clinical trial data, and writing the results section of the clinical study report. Students are expected to have a clear, solid understanding of statistical methods and their applications and a good understanding of SAS software before taking this course.

Note: Successful completion of Biostatistics and SAS Programming required. Students must download and install SAS® OnDemand for Academics: Enterprise Guide. There is no additional cost for this product and it provides access to SAS software through the Internet. Registration and download information will be provided by the instructor after enrollment in the course.

Course Number: BIOL-40254   Credit: 3 units

This course is part of the following Certificate Program(s):

• Biostatistics