25 September 2014

How Conventional And Current Clinical SAS Programmer Should be?

What is SAS?
SAS is a statistical analysis system or software, which enable programmer to write programming language to import or export data, manage data, store and generate the data in a form of report.

A high level of competition is still evolving in pharmaceutical / research / clinical fields for SAS programmers. To catch up with the competition in these fields a SAS programmer has to expand his skill set to meet the new expectations, such as good theory grasp on clinical trial database setup, development of CRF/ECRF's , process of data collection and so on. Apart from these skills, he has to be more effective in communication skills in order to communicate interactively with the stake holders within the working environment.

Traditional role of SAS programmer in pharmaceutical industry:
Traditionally it was followed that a SAS programmer have to usually work with a clean database to create analysis datasets and produce reports as per protocol and any statistical plan they were to use will be provided by the statisticians.

The work flow of programmers were: Import data from disparate data sources, then transform them into useful analysis data sets, generate that into reports like creating tables, listings and figures which will be supporting the clinical reporting processes, export reports to sponsors or other clients for submission to FDA/DCGI for the approval process.

Current Expectations of SAS programmer:
In current situations role of a SAS programmer has been vastly changed due to the limited resources, cost cutting measures and outsourcing strategies by many pharmaceutical industries.

Present work flow of a SAS programmer is: participate in a wide variety of activities such as clinical trial database set up, clinical data management activities, CRF/eCRF designing, annotations, medical monitoring, data quality checking, mapping, and also they are often expected to manage or work with outsourcing partners.

Clinical trial database setup:
SAS programmers are often expected to participate in a clinical trial set up in order to design/address any programming issues, also in addition /deletion of edit checks in data collection tools and should also involve themselves in metadata setup to form friendly database structures.

CRF/eCRF Design:
CRF is the one of the main components of data collection; the best CRF design can reduce the confusions/errors and generate clean data at the time of data collection. SAS programmers have in depth knowledge on data point utilization in the programming part, thus their involvement can be helpful in collecting critical data points.

Annotations of CRF:
Annotated CRF has to be documented and submitted as a part of a product application to the regulatory authorities, in most of the cases Adobe Acrobat professional is used as a tool. A person who is technically good in this tool can perform this job more effectively. Thus a SAS programmer who will be involved in preparing annotated CRFs should have some added experiences on different tools.

SAS programmer with Outsourcing partners:
Due to limited resources, various collaborations and cost cutting measures, a SAS programmer is expected to work with partners in various groups and in different environments like clinical, statistics, programming and so on. Some time they also expected to work as a project lead or programming lead.

Additional skills or tools required for SAS programmer:
Today a SAS programmer is expected to have addition skills, extremely important skills like communication, organization and strong planning, because SAS programmer in asked to involve himself in many activities, interacting with many groups of people in different locations and different backgrounds like (Clinical, Data management, Regulatory, Statistics, vendors, and outsourcing partners etc.), where poor skills may lead to confusion and low productivity.

SAS programmers should be effective in using various types of tools of software applications, like Microsoft Office suite, Adobe Acrobat in preparation of CRF/eCRF annotations; one good example for this is using I-Review tool which is mainly used by most of the pharmaceutical industries to review live data. It can also be used to analyse clinical data from clinical data management system. Thus in the current days it will be very difficult to survive in this field without multitasking capabilities.

Summary:
In order to survive in this competitive world of pharmaceutical industry, new or already experienced SAS programmers cannot rely only on SAS knowledge, they have to be good enough to gain knowledge on different tools/structures of clinical research. Only their added knowledge and experiences combined with their multitasking abilities make them a good SAS programmer.


Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course,  Clinical Data Management Course, SAS Courses and Imaging Training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. 
For more information on Courses and Training contact at: +91 9912868928, 040 64635501.

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