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CLINICAL BIOSTATS

Course Outline

This Biostatistics course covers a comprehensive range of topics essential for conducting clinical trials and analyzing data. The course is over 100 hours of instructional time and includes two real-world clinical trials with simulated data sets to provide practical experience.

The course covers Tables, Listings, Figures (TLFs), including Adverse Events by System Organ Class and Preferred Term, Laboratory, Disposition, Concomitant Medications, Demographics, Swimlane plots, Waterfall plots, Spider plots, and RECIST v1.1 clinical endpoints. Participants will learn how to present data using various graphical and tabular formats to provide clear and concise information to stakeholders.
 
Participants will also learn about SDTM/ADaM data sets, which are essential for standardizing clinical trial data for analysis and reporting. They will learn about dose-finding methods such as 3 + 3 design, BOIN, MCP, and other popular methods.
 
Efficacy Signal Detection methods, including Simon’s Two Stage Design and Fleming’s Two Stage Design, will be covered in detail, providing participants with the skills needed to identify promising treatment options.
 
Multiple Hypothesis Testing, including different types such as Holmes, Benjamini-Hochberg, and Hierarchical methods for controlling the false discovery and familywise error rates, will be explained in detail.
 
 

The course will also cover Sample Size/Power calculations, including continuous, proportional, ordinal, time to event, and group sequential designs. Participants will gain knowledge about Bayesian methods for futility and toxicity gating, as well as Bayesian Hierarchical methods.

The course will include an exploration of common interview questions for Biostatistics, ensuring applicants are well prepared for a typical Biostatistics interview process.
 
Participants will learn the basic principles of Tipping Point Analysis, including the statistical methods used to identify the point of treatment effectiveness. The course will cover different methods for identifying Tipping Points, including graphical and statistical approaches.
 
Participants will learn about Mixed Model Repeated Measures (MMRM) , a statistical technique that is widely used in Biostatistics for analyzing longitudinal data with repeated measurements. This course provides an in-depth overview of MMRM and its applications in clinical trials.
 
Participants will learn the basic principles of MMRM, including the statistical models used to analyze longitudinal data with repeated measurements. The course will cover different types of covariance structures utilized in MMRM, such as Compound Symmetry, Autoregressive, Unstructured, and Toeplitz structures.
 

Participants will also learn about the different study designs required for conducting an MMRM analysis, such as crossover and parallel designs, and how to interpret the results of such analyses.

The course will cover real-world applications of MMRM, including examples from clinical trials. Participants will also have the opportunity to apply their knowledge through practical exercises and case studies.
 
By the end of the course, participants will have a deep understanding of MMRM and its applications in Biostatistics. They will be able to analyze longitudinal data with repeated measurements, which is essential for evaluating treatment effectiveness over time in clinical trials. Participants will also gain the ability to select and interpret the most appropriate covariance structure for their analyses.
 
 
FEATURED COURSES

Level Up Your Skill

Taking our Biostatistics course or our Python programming course is an excellent way to level up your skills and enhance your career prospects. Biostatistics is a high-demand field with a low unemployment rate, and Biostatisticians enjoy higher than average salaries. Python is one of the most popular programming languages in the world and is widely used in data analysis and machine learning. By taking either course, you’ll gain essential skills and knowledge that will make you a valuable asset to any organization in need of statistical or programming expertise. You’ll also learn from industry experts and gain practical experience applying statistical methods or programming concepts to real-world problems. Ultimately, taking our Biostatistics course or our Python programming course is an excellent investment in your professional development and a way to advance your career in dynamic and rewarding fields.
Users Reviews:
5/5

This 12-week Biostatistics course will begin on June 1 and end on August 19, with no classes
on July 3 and 4. Classes will be held every Monday through Thursday from 5:30 pm to 8:30 pm Eastern Standard Time (EST).

Users Reviews:
5/5

This Python programming course is scheduled to have classes every Monday through Thursday from 5:30 pm to 8:30 pm Eastern Standard Time (EST), starting on October 1 and ending on December 21. Please note that there will be no classes on Thanksgiving Day.

Users Reviews:
5/5

This 12-week Biostatistics course will begin on June 1 and end on August 19, with no classes
on July 3 and 4. Classes will be held every Monday through Thursday from 5:30 pm to 8:30 pm Eastern Standard Time (EST).

Users Reviews:
5/5

This Biostatistics course is scheduled to have classes every Monday through Thursday from 5:30 pm to 8:30 pm Eastern Standard Time (EST), starting on October 1 and ending on December 21. Please note that there will be no classes on Thanksgiving Day.