Last modified: 23 Sep 2020 06:16:34 GMT
Role : Principal Statistical Programmer
- Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development.
- Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).
- Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.
- Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.
- Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables. - Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications - Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). - Good communications and negotiation skills, ability to work well with others globally
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