Senior Statistical Programmer

4 weeks ago


Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

The Senior Statistical Programmer will provide timely support to the study team on all programming matters according to the project strategies. This role will lead the programming aspect of a project, both internally or with CROs, for all programming results from the single study through to regulatory approval, product launch, data monitoring boards and annual reports.

Key Responsibilities
  • Work with minimal direction to perform, coordinate and be responsible for the preparation, execution, reporting and documentation of a project.
  • Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current industry standards.
  • Manage the effort, including e-submission results, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming results.
  • Provide programming support for sophisticated presentations and more complex statistical ad-hoc requests.
  • Experience in pharmaceutical clinical development in at least one therapeutic area and ability to provide programming support needs for BLA and other regulatory submissions.
  • Possess Advanced SAS programming skills, preferably in a clinical data environment.
  • Experience in project start-up through submission.
  • Knowledge in creation of current CDISC data structures.
  • Strong understanding of relational databases and experience working with complex data systems.
Requirements
  • We seek a Bachelor's degree required. MS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field preferred.
  • 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry is also needed, including some project and/or people management.


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