Who Should Attend
This course is aimed at non-statisticians (medical doctors, data managers, project managers, statistical programmers, medical writers, regulatory personnel, etc.) who are already working in the field of clinical trials and who have no prior training in statistics.
This basic course is designed for individuals responsible for handling data, documentation writing or management in the pharmaceutical and related industries. The course will benefit individuals in a variety of functions such as:
• Data Management and Statistical Programming
• Quality Assurance
• Regulatory
• Quality Control
• Production
• R&D
• Product Development
• Toxicology
• Vendors/Suppliers
• Clinical Research
• CRO's
Description
This practical 2-day course is designed as an introduction to the statistical principles which form the basis for the design and analysis of clinical trials. It will concentrate on the critical necessity of correct generation of data and understanding of the statistical principles that are used on a day-to-day basis in conducting clinical trials. Throughout the course, all that is needed is no more than a distant memory of high-school math. This will not be a series of lectures on statistical formulae in a cookbook fashion, but instead focuses on gaining an understanding of statistical principles and methods useful in clinical trials.
This course introduces statistical concepts and analytical methods as applied to data encountered in clinical trials. It emphasizes the basic concepts appearing in clinical trial protocols, such as data generation, quantitative analysis of data, and statistical inferences. Topics include statistical distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means and proportions; dose response; and multiplicity. The course provides students a foundation to evaluate information critical to support clinical development and product claims.
Attend this course and its companion course, Biostatistics for the Non-Statistician–Beyond The Basics, ID# 2101 (Offering# 1003-207) and save $500 off the combined regular tuition. (Note: Only one discount applies)