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Clinical SAS Programming

 

Clinical sas programming or Clinical SAS

 

 is a high demand course which is concerned with programming related to clinical trials studies or Clinical Research where a new drug, new surgical or diagnostic procedure is launched into the market by big multinational companies like pharma companies.

Clinical Research: Studies conducted in people, designed to answer specific questions about the safety and/or effectiveness of New drugs, or New devices, New Surgical and Diagnostic procedures and other  therapies.

Recent Public health crisis such as coronavirus (COVID-19) pandemic  which affected  millions of  people. There is a need for research evidence and data to guide public  health systems  in  making effective decisions in health emergencies.

 

With rise in the number of new diseases and disease-causing agents, there is an exponential growth in clinical research. Research in the field of health sciences picked up momentum recently in the 21(st) century 

Unlike other studies clinical research is a lengthy process which  conducted in Phases like Phase I, Phase II, Phase III and Phase IV.

 It  takes years to successfully launch a drug into the market. And the success rate of launching a new drug into the market is also very low. Most of the drugs fail in Phase I studies where safety of drug which is to be launched is established.

The data generated is important and confidential for  clinical trial industry , as the fate of the drug depends on it.

Huge  data is generated in a trial which can be difficult to manage and needs a trustworthy software which can accurately carry on complex analysis on this data , to generate significant, scientifically and statistically supported  results.

 

INTRODUCTION TO SAS

SAS is one of the trustworthy software which is used since long in clinical trial industry.

—  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 through the SAS language.

—  SAS will not make you abandon data formats you previously mastered or managed.(such as Oracle, DB2).

—  SAS is versatile and powerful enough  in data analyses.

—  SAS is flexible, with a variety of input and output formats.

—   It has numerous procedures for descriptive, inferential, and forecasting types of statistical analyses.

—  SAS  helps  healthcare professionals to meet business goals, control costs, generate greater revenue and enhance strategic performance management.

—  SAS programmers play an important role in clinical trial data analysis.

—   In addition to doctors and clinicians  as a part of research team,other s include , group conducting data analysis such as statisticians, clinical data managers (CDMs) and SAS programmers.

—  SAS programmers analyze the collected data to generate summary tables, data listing and graphs for statisticians and or clinicians to write study report.

—  SAS also plays a role in protocol development, the randomization process, CRF designing, adverse event reporting etc.

—  Programming  —  Data could be read from variety of sources, and report could be generated Variety of  file formats such as HTM, rtf, excel, pdf, ppt, csv etc.

—  Programmer s with combined skills in the SAS and other standard programming language (PL/sql, COBOL, Assembler or FORTRAN) could accomplish the tasks more quickly with SAS .

—  SAS tools are used to explore clinical outcomes and risk tolerances to improve quality.

—  Data management system –  SAS could be  used to create, alter, update, maintain and secure database through SQL.

—  Other statistical software such as SPSS, can generate their results into SAS datasets for use in the SAS.

—  Research data is submitted to FDA in SAS Transport File format(.xpt)

 

CLINICAL SAS PROGRAMMING PROCESS

—  Clinical Trial SAS programming (Clinical SAS):is a Research Oriented programming where

—   The Raw research Data is Accessed from different sources such as excel, text, database etc.

—  Explored for any discrepancies, cleaned for duplicate, null values etc.

—   Filtered and processed for extracting relevant information.

—  Computed new information(columns) using functions.

—  Analyzed by using various statistical measures , and Transformed into relevant structure, and finally generating reports and exported  in different formats(HTML,PDF, EXCEL,RTF,CSV,PPT,)

—  The final data is standardized as per CDISC Standards using SDTM, ADAM, DEFINE implementation guides.

—  The standardized Data  submitted to the FDA for Approval of New Drugs.

—   The Analysis results are also converted in the form  Tables as per SAP, Listings,  and graphs.(TLFS)

 

        IMPORTANCE

—  SAS programmers plays an important role in clinical trial data analysis.

—   The opportunities for SAS programmers to address the technical needs in healthcare industry are ever expanding.

—  Clinical SAS provides a number of analytical tools used to explore drug result and risk tolerances to improve the quality of patient care.

—  A clinical SAS training will enable you to formulate ideas and methods for data analysis.

 

—  SAS play a major role in clinical trials, right from defining the clinical study to till regulatory submission.

—  Clinical SAS training can help you bag some impressive jobs in healthcare industry.

—  The clinical SAS programming industry, has seen a rapid growth in this decade and the trend seems set to continue.

—   SAS professionals are finding employment opportunities above and beyond crunching numbers.

—  According to a recent study, SAS analytics skills are the most valuable skills to have in today’s job market.

—  In Multinational Companies like Novartis, Glaxo Smithkline, Pfizer, Roche there are a lot of scopes for clinical SAS programmers.

 

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