Senior Analyst, Statistical Programming

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.As the Senior Analyst, Statistical SAS Programmer , you will be responsible for the development, testing, validation, documentation, maintenance, and execution of SAS programs. This individual will primarily be providing statistical programming support for TMTT Clinical Affairs department.This role can be remote, hybrid or onsite. For hybrid or remote employees, this will be include regular trips to the Irvine campus.Job Functions including but not limited to :

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

Basic Qualifications:

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)

Good understanding of statistical techniques

Proficiency in MS Office Suite

Preferred Qualifications:

Advanced proficiency with R

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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $111,000 to $157,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.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.