Quality, Efficiency and Industrialisation Initiatives during the evolution of a dedicated SAS Programming Group
Gregory Pinault, Aurelie Gautier, Goonaseelan Pillai, Jean-Louis Steimer, Vincent Buchheit
M&S, Novartis, Basel Switzerland
Objectives: We previously described the role, advantages and experiences of a dedicated SAS Programming Group working in a pharmaceutical Modeling & Simulation organization [1]. Since its creation, the demand for the skills and services of the Novartis M&S Programming group has increased and grown in tandem with the increase in size of the core modeling group. The authors would like to highlight the opportunities and challenges that this fast development entailed, and to collect feedback on strategies for role expansion and career development for associates working in such a group.
Methods: The programming group has had a net doubling in size in 2 years. The M&S organizational structure evolved into a matrix arrangement comprising the 4 core discipline functions (Biology, Pharmacology, Statistics and Programming) and 8 therapeutic area clusters, loosely matching the global organization of major partner and client groups of the M&S department. Each programmer is assigned to one of these groups. Several quality, efficiency and industrialization projects were initiated and will be described in this presentation.
Results: Analogous to an M&S project, success in increasing the group size entailed analysis of historical demand for the group’s services (modeling) as well as prediction of the future influence and impact of the programmers within the whole M&S group (simulation). This served to convince management of the needs (headcount and infrastructure) as well as defined the hiring and on-boarding strategy for new hires. The core competencies of the programming group requires: proficiency in ≥ 1 programming language, skills in working with databases, an appreciation of pharmacology and study design, an eye for potential data quality issues, an in-depth understanding of the regulatory requirements, and how the data will ultimately be modeled. Infrastructure to support activities being currently developed: Guide to M&S Programmers, on-line form for dataset specification, SAS tool kit, and Literature database.
Conclusions: We remain convinced of the critical role for a dedicated programming group that is integrated within an M&S department. Attracting, developing and retaining associates in such a group requires special efforts to distinguish the group from the traditional roles played by SAS programmers in a Pharma company.
References:
[1] Buchheit et al. 2007. A dedicated SAS Programming Group working in a pharmaceutical Modeling & Simulation organization - Current role, experience and prospects . PAGE 16 (2007) Abstr 1122 [www.page-meeting.org/?abstract=1122].
