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SAS is widely used in clinical trial data analysis in pharmaceutical, biotech and clinical research companies. SAS programmers play an important role in clinical trial data analysis. In addition to doctors and clinicians who collect clinical trial data, the group conducting data analysis includes statisticians, clinical data managers (COMs) and SAS programmers. Statisticians provide the ideas and methods of the data analysis, clinical data managers manage the collected data and control the data quality. In between, SAS programmers implement the analysis methods on the collected data and provide the study summary tables, data listing and graphs to the statisticians andlor clinicians to write study report. SAS programmers work closely with statisticians and data managers. They provide the link between raw data and the analysis. This paper discusses the SAS programmers' roles in the clinical trial data analysis task flow, describes the SAS programmers' tasks and skills, and provides insight on how to work with people in the team.
Validation is a critical component to programming clinical trial analysis. Essential to effective validation is the programmer's understanding of the data with which they'll be working. If you don't understand how the data is arranged, the values that are reasonable for each variable, and the way the data should behave, you cannot ensure that the final result of your programming effort is complete or even appropriate. Therefore, to be a successful programmer in the pharmaceutical industry, you need to understand validation requirements and to learn how to make the code do the bulk of the work so that your programs are efficient as well as accurate. This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and in your output topics addressed include:
Validating Clinical Trial Data Reporting with SAS is designed for SAS programmers who are new to the pharmaceutical industry as well as for those seeking a good foundation for validation in the SAS programming arena. Readers should have a working knowledge of Base SAS and a basic understanding of programming tasks in the pharmaceutical industry.
In Information and Technology area, managing huge databases and analyzing the data is a challenging task. For managing data, warehouses are created as per the client’s specifications and requirements and variety of software tools are used to process the data.
Statistical Analysis System, known as SAS System, is one of the most widely used, flexible data processing tools. It is used to perform:
The core of the SAS System is base SAS software. It consists of SAS language: It is a programming language that you use to manage data Procedure that are software tools for data analysis and reporting A macro facility, A windowing environment called the SAS Display Manager System.
SAS is a software suite that can mine, alter, manage and retrieve data from a variety of sources and perform statistical analysis on it. SAS provides a graphical point-and-click user interface for non-technical users and more advanced options through the SAS programming language. SAS programs have a DATA step, which retrieves and manipulates data, usually creating a SAS data set, and a PROC step, which analyzes the data.
Each step consists of a series of statements.The DATA step has executable statements that result in the software taking an action, and declarative statements that provide instructions to read a data set or alter the data's appearance.The DATA step has two phases, compilation and execution. In the compilation phase, declarative statements are processed and syntax errors are identified. Afterwards, the execution phase processes each executable statement sequentially.Data sets are organized into tables with rows called "observations" and columns called "variables". Additionally, each piece of data has a descriptor and a value.
The PROC step consists of PROC statements that call upon named procedures. Procedures perform analysis and reporting on data sets to produce statistics, analyses and graphics. There are more than 300 procedures and each one contains a substantial body of programming and statistical work.PROC statements can also display results, sort data or perform other operations. SAS Macros are pieces of code or variables that are coded once and referenced to perform repetitive tasks.
SAS data can be published in HTML, PDF, Excel and other formats using the Output Delivery System, which was first introduced in 2007. The SAS Enterprise Guide is SAS' point-and-click interface. It generates code to manipulate data or perform analysis automatically and does not require SAS programming experience to use.
The SAS software suite has more than components Some of the SAS components include:
Before analyze the data and produce the final report we have to arrange the data in the order (format) that the software will recognize the data for further processing. SAS will recognize the data in the form of data set. SAS data set consists of two parts i.e.Descriptor information: This describes the contents of the SAS data set to the SAS System. Data values: Data that have been collected or calculated which is organized into a rectangular structure containing rows called observations and columns called variables.
SAS language consists of statements. Each SAS statement is terminated by semi-colon (;) When SAS program is executed, log and lst (list or output) files are created by the system.
Log file contains the Error messages, Warnings and Notes. Whenever we run the SAS program, the first step is to open the log file and check for the errors, warnings and notes. This will help us the make the SAS program error free. When the log file is no errors, no warnings, no notes (it displays at the bottom of the log file specifying Warnings 0 Errors 0 Notes 0) then we can confirm that the processing is accurate.
Output file It contains the results of the processing. Base SAS mainly completes with two steps called Data Step and Procedure Step.
Data Step It is used to create data sets. Proc Step is used to execute the pre-defined procedures that are used for processing.
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