Clinical SAS® Programming: Analysis and Mitigation of Risk
Parag Shiralkar, eClinical Solutions, A Division of Eliassen Group
SAS® programming is an important function of clinical reporting work in pharmaceutical industry. Despite
importance of SAS® programming in clinical reporting work, several factors at various levels of organization impact
the productivity of programming as a ‘business function’. These factors originate from the dynamics within an
organization and the dynamics of the industry and often develop various types of risks in programming projects.
While managing programming projects, project managers often need to deal with such risks. Most of the time such
risks impact directly on the product delivered by the programming services. In some cases such impact is clearly
visible financially through time and money lost in fixing the errors or in dealing with less priority work.
This study explores factors which may cause deviation of risk from the perceived risk by the project
managers working on SAS® programming projects. Analysis of such deviation of risk and the ‘management’
experience of project managers can provide valuable findings about how project managers working on clinical SAS®
programming projects should be mentored and should be prepared for risk mitigation.
Role of SAS® Programming in clinical reporting environment is often attributed to meeting the reporting
needs of the clinical team working on a clinical protocol or on a drug submission. Such reporting needs often include
development of reports, graphs, queries, and datasets for submissions as well as for ad-hoc reporting requests.
While perceiving SAS® programming as a function of an organization, primary objective of such function is to meet
the clinical reporting needs in a qualitative and cost effective manner. Management can meet reporting needs in a
qualitative manner by ensuring availability of appropriate reporting environment and skilled and