Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of clinical trials the part they play is ever evolving. In this blog, we take a look at 5 trends which are shaping their roles in 2016 and beyond.
With the advent of mandatory CDISC compliant submissions for the FDA and PMDA, CDISC is sure to continue to shape roles in statistical programming. As well as gaining hands-on experience in SDTM and ADaM programming, increasingly programmers look to bring extra value by becoming CDISC subject matter experts. Participation in CDISC user groups and conferences can ensure programmers keep up to speed with the latest regulatory guidance as well as therapeutic area specific requirements. For those just starting out in statistical programming, Cytel’s ClipLab offers an online course in CDISC Mapping and CDISC also offers its own public courses and online courses.
2) Data Visualization
Data visualization is inextricably linked with working with large datasets. This is obviously a trend of the industry as a whole, and in particular for statistical programmers working in non-clinical or outcomes research settings. Within the clinical trial environment, data visualization is also rising in importance. It is invaluable for promoting the understanding and interpretation of data, as well as supporting interdisciplinary communication and decision making about the clinical trial.
The statistical programmer holds an integral role as part of the clinical study team, interacting heavily with statisticians and data managers as well as with their sponsor or CRO counterpart. Soft skills including communication, teamwork, management of virtual teams and consultative abilities are all important. There is a trend in the industry (both in CRO and sponsor environments) for statistical programmers to work remotely. This means that the statistical programmer will need to be even more adept at forging relationships with other members of their virtual teams.
5) Need for Innovation
The pharmaceutical industry is suffering from the twin challenges of lack of innovation on the one hand, and cost containment on the other. In this climate, it’s imperative that the industry continually improves and brings new drugs to patients faster. The statistical programmer has a vital role to play in this paradigm. Indeed the theme of this year’s PhUSE conference is improving time and efficiency, with the organizers asking the question ‘How can we standardize, automatize, design trials and utilize data more effectively to reduce the time to approval?’ It's critical for statistical programmers whether in a CRO or biopharma environment to have a mindset geared to process innovation and improvement- how can we do things faster and more efficiently, while maintaining the highest standards of quality? By developing strong knowledge and understanding of your organization’s current processes, and keeping up to speed with industry trends, technologies, and approaches, the statistical programmer can play an important role in streamlining the path to regulatory approval.
Cytel is committed to developing the skills of its employees and providing a working environment which fosters innovation. Find out more about our careers in statistical programming by clicking below.