Embracing and Implementing the Changes in Statistical Programming Instead of Just Trying to Keep Up with Them

Actelion Pharmaceuticals, Gewerbestrasse 16, 4213 Allschwil Switzerland

Statistical programmers in the pharmaceutical industry have been enjoying the steadiness of their jobs for many years. Perhaps, too many. The pattern of joining a company has always been the same: get to know the Statistical Computing Environment (SCE), get to know the standard macros, produce .pdf outputs. A new job most likely means a new statistical computing environment, new standard macros, a few months acclimatising and that’s about it. However, in recent years we have observed major changes in the workflow in pharma across various functions in clinical development and beyond – not only triggered by statistical programming but also due to emerging technologies. New programming languages have come to stay; new ways of working have been put in place; new requirements have emerged in the job descriptions. On the one hand, it’s no longer enough producing .pdf outputs using your company’s standard macros, tools and processes. On the other hand, is the new approach always better just because it’s new? Should we completely abandon the old tools or should we seek for the balance and cherry-pick from all the tools available?

At this SDE we invite you to discuss how statistical programmers and data scientists can embrace the change as well as drive the change themselves.

Here are some suggestions for topics and ideas you might want to share:

– Choosing fit-for-purpose tools

– Upskilling in new languages/technologies

– Evaluating the benefits and risks of using different programming languages and environments

– Choosing between open-source and in-house solutions

– Validation, traceability, audit readiness and reproducibility while using open-source software

– Solutions for collaborating within teams, across teams or even across organisations within pharma development or beyond

– Submission experience

– Mindset in embracing the changing landscape

– Feedback routes and suggestions to technical leaders