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 had an introductory course in statistics, or at statisticians with little or no experience in clinical trials.
This basic course is designed for individuals responsible for handing 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 intensive 3-day course is designed to bring the student beyond the basic concepts of basic statistics frequently encountered in clinical trials. It will concentrate on the critical necessity of understanding fundamental differences between various clinical trial designs, analysis and the feasibility of carrying out the various approaches. Throughout the course, all that is needed is alertness to the consequences of decisions made regarding statistical methods and analysis in clinical development. Although, some of the methods presented have a deep mathematical foundation, this course will not be focusing on statistical formulae, but on gaining an understanding of critical statistical decisions made by statisticians and non-statisticians day-by-day in clinical drug development.
Topics include the cross-over design, bioequivalence, survival analysis (Life table; Log rank; Cox model), recurrent events analysis (Andersen-Gill, marginal Cox models, Negative binomial regression), Bayesian, Data mining, Dimension reduction, Adaptive methods, Regression methods, and nonparametric methods.
Attend this course and its companion course, Practical Biostatistics for the Non-Statistician–The Basics, ID# 468 (Offering# 1003-206) and save $500 off the combined regular tuition. (Note: Only one discount applies)