–Written by Rabia Ahmad, Programming Leader at GSK Please note, this blog is the opinion of the author and does not represent PHUSE nor necessarily the opinion of the authors employer.

Recently I came across an NESUG 1996 paper, “The Role of SAS Programmers in Clinical Trial Data Analysis”. It’s an interesting read – if only to note how much the programming role in clinical trials has evolved in the past two decades. First, the role is not limited to the use of SAS only. Second, clinical trial data analysis has now become a small portion in the larger scheme.

Interestingly enough, the change in the mindset of clinical programmers and their stakeholders (about the role of clinical programming) has failed to keep pace with the change in expectations from them. It is vital for clinical programmers to acknowledge and understand this disconnect, because reducing the gap will help them become stronger and more valuable members of the study/project team. To do so, the important question to ask is, “What do we expect from a clinical programmer?” Of course, there is no one definition or definitive set of attributes. However, there are certain key ones that come to mind.

1. Agility:

A clinical programmer, on the same day, can debug an SAS macro, dabble with the R Shiny app for data exploration and meet with the clinical team to explain how the protocol-defined end of study data is captured and can be reported. In short, they wear many hats – as a result, being able to write complex SAS code is great, but the ability (or agility) to adapt and stretch their experiences, skills and approach to fit the situation is simply outstanding.

2. Functional Experts:

There is a reason an entire function of “clinical programming” exists – it is because clinical programmers are the experts in translating the protocol/SAP defined analysis into readable and validated reports. So, clearly, they must take the lead to provide insight, review, and drive how the protocols & SAPs are written, eCRFs are designed or displays are specified. They must ensure that study/project specifications facilitate implementing the most time- and resource-efficient processes to develop reports compliant with both the industry & company standards.

3. The Power of “And”:

The separation between “technical” versus “non-technical” skills is fast disappearing. Gone are the days when programmers were heads-down, technical resources for the Biostatistics function, following pre-defined specifications to produce analysis datasets and TFLs. Today, clinical programmers possess technical strength and build relationships and influence their stakeholders and represent the programming function and manage projects and lead global programming teams – and this is just the beginning. All of this demands them to exhibit a “hybrid” and “fluid” set of skills – knowing precisely what mix of each is needed to best address the problem, situation or question at hand. Tomas Chamorro-Premuzic summarises this concept best in his article, “Thriving in the Age of Hybrid Work”: ‘(W)here we were once ruled by “either-or”, we are now seeing the rise of “and”.’

4. Innovate the Future:

The role of the clinical programmer is not for today, but tomorrow. They are never satisfied with the status quo and tenaciously try to identify areas of improvements. They define programming and reporting standards, pilot new processes to develop efficient study/project management, participate in novel initiatives (both internal and external) to influence future standards, SOPs & ways of working, develop functional and personal competencies – again, just the beginning. In short, clinical programmers innovate and define the future of programming efficiencies, processes, methodologies, their role and the role of clinical programming as a function – the possibilities are endless.

To wrap up, the role of a clinical programmer is not limited to SAS programming and developing analysis datasets and reports. Programmers are expected to possess and exhibit a combination of technical and soft skills. This allows them numerous opportunities to transition and demonstrate their abilities in different areas and help redefine the role and value of the clinical programming function within the study/project teams.

References:

Wang, M. (1996). The role of SAS programmers in clinical trial data analysis. NESUG.

Chamorro-Premuzic, T. (January 13, 2021). Thriving in the age of hybrid work. Harvard Business Review Digital Content.

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