Edwards Lifesciences Analyst, Statistical Programming - Transcatheter Heart Valve in Irvine, California
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.
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
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
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 is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.