India is moving from the generic bulk drug manufacturer to one of key player in clinical research industry. Clinical trial analysis and reports submission using SAS software is one of the key activities carried out as part of the clinical research. Due to high availability of skilled resources, innovative capacity and reduced costs this particular segment of resources is highly recognized and more work is being outsourced currently than in the past. As in any scenario, when the supply cannot keep up with demand, it always leads to numerous challenges. This paper is aimed to study the balance between the industry needs and the programmers want and also reflects on its impact, with the current challenges faced by the management.

The clinical SAS programming industry, in India, has seen a rapid growth in the last decade and the trend seems set to continue, for the next couple of years, due to cost advantage and the availability of skilled labor. On one side the industry needs are focused on less execution time, high margins, segmented tasks and the delivery of high quality output with minimal oversight. On the other side, due to the increased demand for skilled resources, the wants of the programmers have taken a different shift toward diversifying exposure, unsustainable wage inflation due to multiple opportunities and generally high expectations around career progression. If the industry needs are not going to match with programmers want, or vice versa, then there is the possibility that the current year on year growth may start to slow or even go into decline.

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.

Anyone wanting to get into the Life Science / Pharmaceutical industry and looking to work in this field or Want to take up a job as a Clinical SAS Programmer in a Pharma company or a CRO (Contract Research Org.) can join this course. Basic SAS programing will be taught at the rquest of the participants as a prerequisite.

• 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.