This course is designed to equip students with essential statistical knowledge and skills necessary for the successful clinical trial design and analysis. This course covers a wide range of statistical topics specific to clinical trials, including intention-to-treat versus efficacy trials, principles of sampling and exclusion, methods of allocation and techniques of randomization, parallel versus cross over design, cluster randomization designs, statistical analysis planning, external and internal validation, and reports of statistical findings. Additionally, the course will explore other selected topics related to logistical issues in the management of clinical trials. Prerequisite: consent of the instructor. Notes: Students outside of the course-based MSc with a specialization in Biostatistics need permission from the Department to enroll in this course. Thesis-based graduate students in Mathematical and Statistical Sciences cannot take this course for credit.