Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the development of new medicines. In a dynamic industry with demands such as CDISC compliance, data transparency initiatives, big data, and cost pressures the role is evolving to become ever more multi-dimensional. Statistical programmers now have the opportunity to follow their specific interests and specialize in a range of areas.
There can be overlap between the role of a statistician and statistical programmer, and indeed many statistical programmers also have advanced degrees in statistics. Where the statistical programmer customizes the data to produce an output which displays the behavior of the data, the statistician rather infers the conclusion from the data.
Certain aspects of the statistical programmer role are rather more closely aligned with the statistics function. A primary function of the statistical programmer is to create programs to generate the Tables, Listings, and Figures needed for the analysis and reporting of the clinical study. A solid statistical grounding in the statistical programmer can add value to these activities, and the statistical programmer may be able to take on traditionally statistical aspects such as the creation of table specifications and mock shells.
Other programmers may focus more on data handling and data management aspects. This has become increasingly prevalent , with a heavy emphasis in statistical programming work on creation, mapping, and programming of SDTMs. Other key responsibilities include reviewing the Case Report Forms (CRFs) and the database structures where the data will be stored. Programmers who focus on these areas will tend to be aligned more closely with the data management function, and may have opportunities to be involved in data standards creation, management, and governance. Managing data submissions is also a key role, and often a statistical programmer may lead the production of the ECTD module 5.
Improving efficiency is an important goal in statistical programming within CRO and sponsor environments alike. In some roles, statistical programmers may be specifically tasked with identifying areas where efficiencies can be gained and improving processes. This can involve the development of macros and utility programs, and evaluation and introduction of new technologies including visualization tools.
Resourcing and Project Management
Whether in a CRO or a sponsor environment, the effective management of resourcing is critical for effective statistical programming delivery. Depending on the size of the team, a specific role may exist for a senior programmer to assign tasks, forecast peaks and troughs of work and project manage the delivery of the work. Within a sponsor, it could involve working with outside vendors, or within a CRO acting as governance and liaison with sponsors. However, it’s important to maintain some direct programming involvement to keep hands-on skills current.
With such a variety of responsibilities, it's critical that the modern statistical programmer is adaptable and invests in personal development. We need to continuously update our technical skills and keep abreast of the industry and regulatory trends affecting our roles. Not least, we must invest time in continued development of those soft skills of communication, project management and leadership which are increasingly important in the day to day lives of today's statistical programmers.
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