Different levels in SAS programming and their responsibilities

Statistical programmers work with statistics, which are the numbers that researchers and scientists gather by analyzing large pools of numerical data. These programmers monitor productivity to ensure that programming complies with the government standards and the standards of the client. They can evaluate programming processes and suggest revisions geared toward increasing productivity.

There are multiple levels in SAS programming, they are:

Junior level SAS programmer: Clinical SAS Programmer position would play a vital role in writing programs needed to generate tables and listings for clinical data on assigned projects. Junior SAS Programmers would be responsible for creating, modifying and maintaining programs, primarily in SAS, in effort of supporting the clinical data management department. This includes, but is not limited to: “Manual” Data Quality Checks (DQC), Data Review Listings, Data Extracts, Data Mapping and Importing External Data Files (EDF).

This level programmer should also have good knowledge to help design data review specifications. They would need to manage and manipulate multiple large (SAS) data sets, including, but not limited to: defining data, reviewing data sets and variables, performing calculations and providing summarizations. This role also requires candidates to prepare specific data review deliverables and combine multiple data sets needed to create cohesive data review reports.

Data Management Programmer: This level of programmer should have at least 4 year of experience. As a clinical programmer, there are many paths to take. The main goal is always to access the data, manipulate and transform the data, analyze the data and report on the data. As a programmer, one can specialize in data management (DM) programming and spend a majority of the time cleaning the data through edit checks and work on the creation of patient listings and profiles. Another task of the DM programmer is to transform the data from its raw format into a standard format. This standard format could be the CDISC Study Data Tabulation Model (SDTM) that is requested by regulatory agencies upon submission of a new compound or it could be a sponsor’s own standards. In the process of transforming the data, the DM programmer must make sure that the output conforms to the standard and is compliant as well as valid. So another part of the job is to write programs to check the data against the standard and run the programs whenever a new study data is about to be analyzed. Finally when all of the data has been transformed, the DM programmer must create a transport file that will be sent to the regulatory agency that will review the submitted data.

Clinical Data Integration SAS Programmer: Clinical Data Integration SAS programmer makes full use of the SAS Data Integration Studio and adds additional functionality related to clinical data integration. This includes the essentials for using SAS Data Integration Studio to register source and target tables and to create and manage transformations to read and manipulate data. To become one such programmer, a candidate should have good knowledge on how to import CDISC standards (or other standards) for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, to validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files describing the domain tables for clinical submissions. He/she should be good in methods to monitor the status of clinical data integration projects and to promote new domain structures created within clinical projects to customized standards available across the organization.

Clinical Programmer (Data Management based SAS): Data managers are SAS programmers who can access and manage data to perform quick queries and analyses. They have the responsibility to develop, program, test and maintain clinical trial databases and data entry screens using oracle clinical, RAVE or Central Designer in accordance with Client standards. They also review computer validation/edit checks for in-house and outsourced studies and develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS. They also review listings in Oracle Clinical, Inform, J-review and/or SAS for data review purposes. They should also be good to perform external data loads, i.e., lab tests, ECGs, etc., as needed and validate peer programming. In addition to these tasks, they also must provide technical expertise and support to the Data Management team, have control on the access to database and perform snapshots, database lock and freeze activities, make data, including interim data, available to company personnel and regulatory agencies when required. Finally they should take up the responsibility to train and advice junior programmers to identify problems and solutions.

Clinical SAS Programming Manager/Team Leader/Project Manager/ Head of SAS programmer: Responsibilities of a candidate in the managing level in SAS are to provide statistical programming support on all development projects, presentations and publications. They should be able to manage the activities of other statistical programmers, contractors and CROs. Other roles and responsibilities of a SAS programming manager are: to program statistical analysis of the clinical data under the direction of a Statistician, manage internal programming staff and coordinate statistical and programming support for various projects, collaborate with partner company data managers, statisticians and programmers on analysis plans for global filing of marketing applications, generate data listings, tables and figures from clinical data using SAS or other statistical softwares, collaborate with clinical, medical writing and regulatory for clinical reports and FDA submissions, review clinical protocols, SAP and case report forms, provides primary and secondary programming support as needed.

Conclusion: Thus, there are different levels of SAS programmers based on their knowledge levels and responsibilities to be undertaken and fulfilled. One can enhance their position by upgrading their skills and gaining experience in various SAS domains.

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