This course includes
- 2 hours on-demand video
- Full lifetime access
- Access on mobile devices
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Certificate of completion
Aslam Khan
Meet your expert trainer for this course!
A certified Program Management Professional (PgMP), Project Management Professional (PMP) and a SAS Base and Advanced Certified Programmer, with a Master's Degree in Management Information Systems, Alsam will guide you through the sometimes complex concepts by breaking them down using simple illustrations and easy to understand language. His very intuitive approach will ultimately help you understand, learn and retain the topics of interest.
Base course
Learn the course content at your own pace. If you have questions or curiosities, you may want to pay just a little more and have the possibility to interact directly with the expert trainer.
Have a look at the course with the "Expert Support Available" tag.
What you'll learn
- Get introduced to the Life Science/ Pharmaceutical industry in simple, visual pictures
- Learn the fundamental concepts of Clinical Drug Development / Clinical Trials processes
- Understand the various Phases of Clinical Trials in the context of SAS programming
- Get introduced to the various clinical study documents like Protocol, Statistical Analysis Plan etc.
- Understand raw data and how it is collected, stored, analysed and reported
- Work hands-on with sample study data that you will import, prepare, restructure and visualize
- Generate an actual Clinical Study Reports from the derived data you will create
- See for yourself how SAS programming is an integral part of putting a drug into the market
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A guide to the SAS Certified Clinical Trials Programmer Using SAS®9 Certification Exam
Requirements
- Basic SAS Programming
- No prior Pharmaceutical experience is necessary
- Internet connectivity for working in the SAS Studio Edition using SAS OnDemand (no installation necessary)
Prerequisites
You will need basic SAS programming knowledge to work with code discussed in this course. You can take my course on SAS programming ("The Simplest Guide to SAS Programming") available on Pharma Training Hub.
Who this course is for
- Anyone wanting to get into the Life Science / Pharmaceutical industry and looking to work in this field
- Want to take up a job as a Clinical SAS Programmer in a Pharma company or a CRO (Contract Research Org.)
- Want to just play with data using the SAS Programming concepts
Earn a Certificate
When you finish watching the course, you'll earn a Certificate that you can share with prospective employers and your professional network.
Description
This course gives an introduction to the Pharmaceutical/ Life Science industry in a simple and visual style that is easy to understand. It shows how SAS is used as a tool to work with the vast amount of clinical data within this industry. The course takes you through an example clinical study sample data, and generate various Clinical Study Reports that are submitted to the FDA (in the US) or other regulatory authorities in other countries. You will not only hone your SAS programming skills but will also learn essential concepts needed to work in the Pharma industry in the areas of Biostatistics and Clinical Data Management.
After the introduction to the pharma industry and learning relevant concepts about Clinical Trials, the course takes you through a hands-on training exercise to build the very important and fundamental Clinical Study Report called the Demographics Table.
You will begin with a sample clinical study data in an Excel sheet, then you will import it into SAS, derive all necessary variables as shown in the mock table, and finally generate a clinical study report. All this will be done using guided SAS Programming steps with detailed explanations at every step of programming. At the end of this course, you will have learnt to work with Clinical Study Data, generate a real Clinical Study Report, and extend those steps to build other reports that constitute Clinical Trial submissions to the regulatory bodies.
Example Curriculum
- Introduction to Clinical Trials (1:04)
- 1. Course Overview (1:21)
- 2. Components of the Pharma/Life Science Industry (4:40)
- 3. Phases of Clinical Trials (5:41)
- 4. Data and Reports in Clinical Trials (3:55)
- 5. Types of data in Clinical Trials (4:34)
- 6. Section conclusion (0:40)
- QUIZ 1 - Clinical Trial Fundamentals
- 7. Get to know the Clinical Study Documents - Overview (0:39)
- 8. Study Documents - The Clinical Study Protocol (2:10)
- 9. The Informed Consent (1:09)
- 10. The Inclusion-Exclusion Criteria (0:35)
- 11. The Statistical Analysis Plan (SAP), Mock shells and Case Report Forms (CRFs) (3:38)
- 12. Conclusion (0:10)
- QUIZ 2 - Clinical Study Documents
- 13. Building the CSRs - Overview (1:04)
- 14. SAS Studio through SAS OnDemand- Registration (3:22)
- 15. Logging-in to SAS after registration (0:54)
- 16. General SAS Programming Steps for building any CSRs (2:15)
- 17. Understanding Demographics Case Report Form (CRF) (4:18)
- 18. Understanding the Demographics Table (3:18)
- 19. Planning to program the Demographics Table (5:11)
- 20. Importing raw Demographics data into SAS (3:13)
- Resources - Importing raw Demographics data into SAS
- QUIZ 3- Building the Demographics table
- 21. Deciding which PROCs to use (1:43)
- 22. Deriving the AGE variable (10:14)
- 23. Obtaining Summary Statistics for AGE (3:37)
- 24. Adding the 3rd treatment group using Explicit Output (5:21)
- 25. Deriving the SEX variable (3:21)
- 26. Obtaining Summary Statistics for SEX (3:08)
- QUIZ 4 - Procedures and Variables
- 27. Concatenating the COUNT and PERCENTAGE variables (2:51)
- 28. Deriving the RACE variable (2:47)
- 29. Obtaining Summary Statistics for RACE (2:55)
- 30. Stacking all 3 Summary Statistics together (5:42)
- 31. Fixing the precision points (3:54)
- 32. Transposing data (2:44)
- QUIZ 5 - Structuring Data
- 33. Fixing the order of Statistical Parameters (5:05)
- 34. Building the final report (1:51)
- 35. Putting the final touches to the report (10:39)
- Resources
- 36. Building the CSRs - Section conclusion (0:33)
- QUIZ 6 - Final Report
- Final Test
