Edwards Lifesciences Senior Analyst, Statistical Programming - Transcatheter Heart Valve in Irvine, California
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
The Senior 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 complex analysis datasets, specifications, and summary output (tables, listings, or graphs) for inclusion in clinical reports or presentations; Create complex programs that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (e.g SAS)
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 complex analysis in response to data requests in collaboration with designated statistician
Collaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checks
Bachelor’s degree in Biostatistics, Statistics, Mathematics, Computer Science, Bioinformatics, or Engineering, with 4 years of statistical programming experience OR Master’s degree in Biostatistics, Statistics, Mathematics, Computer Science, Bioinformatics, or Engineering, with 2 years of statistical programming experience
Advanced SAS programming skills (SAS/BASE, SAS/STAT, SAS/GRAPH)
Advanced proficiency with R
Good understanding of statistical techniques
Proficiency in MS Office Suite
Experience with Python at intermediate level
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 15,000 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.