Senior Statistical Programmer overseeing statistical programming and analytics for drug development studies at Novartis in Switzerland.
Responsibilities
Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities
Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables
Oversees programming style, quality of statistical reporting & compliance with timelines
Lead statistical programming activities as Trial Programmer for several studies or as Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies
Co-ordinate activities of programmers either internally or externally
Make statistical programming decisions and propose strategies at study or project level
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities
Requirements
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
Work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
Advanced 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)
Proven communications and negotiation skills, ability to work well with others globally and influence
Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others
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