Analyst, Statistical Programming - Transcatheter Heart Valve

Edwards Lifesciences

  • Irvine, CA
  • Permanent
  • Full-time
  • 2 months ago
This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.

The Analyst, Statistical Programming is a newly created opening for the development, testing, validation, documentation, maintenance, and execution of SAS programs. This individual will primarily be providing statistical programming support for THV Clinical Affairs department.

Job Functions:
  • Develop or modify analysis datasets for inclusion in clinical reports or presentations; Create programs for summary output (tables, listings, or graphs) that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (SAS or R/RStudio)
  • Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review
  • Perform analysis in response to data requests in collaboration with designated statistician
  • Create statistical programming related documents
  • Participate programming standardization infrastructure buildup
Basic Qualifications:
  • Bachelor’s degree in Biostatistics, Statistics, Mathematics, Computer Science, Bioinformatics, or Engineering, with 3 years of statistical programming experience OR Master’s degree in Biostatistics, Statistics, Mathematics, Computer Science, Bioinformatics, or Engineering
  • Strong SAS programming skills (SAS/BASE, SAS/STAT, SAS/GRAPH)
  • Proficiency with R, RStudio or Python
  • Good understanding of statistical techniques
  • Proficiency in MS Office Suite
Preferred Qualifications:
  • Experience in clinical trials within the medical device, pharmaceutical, or biotech industry
  • Good communication skills
  • Eager to learn and be proactive in chasing solutions to problems or achieving results
  • Attention to detail
  • Ability to manage and prioritize multiple projects
  • Ability to work effectively as a team member
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences