Principal, Statistical Programming

 Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

How you’ll make an impact:

• Lead statistical programming activities as a lead programmer for a study or projects, co-ordinate activities of supporting programmers
• As a Subject Matter Expert (SME), mentor other junior programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.
• Review eCRF, participate UAT testing during database build
• Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project level, review and develop programming specifications as part of the analysis plans.
• Responsible for development of SDTM and ADaM specifications according CDISC standards and internal process.
• Ensure timely and quality development and validation of datasets and tables/figures/listings for regulatory submissions, publications and podium presentations.
• Create internal routine reports to support data cleaning, safety review, and clinical trial operation conduct.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results following company Global Instructions.
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS and R) as well as industry requirements (e.g. CDISC SDTM/ADaM etc.), attend functional meetings and trainings.
• As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.
• This position is in office, Irvine, California. Relocation is available.

What you'll need (Required):

Bachelor's degree in Statistics, Data Science, Computer Science or related field with 6 years’ experience of previous experience in statistical analysis is required or Master’s degree with 5 years’ experience or Ph.D. with 2 years’ experience is required.

What else we look for (Preferred):

• Advanced SAS experience and proven skills in the use of SAS within a statistical programming environment to develop and validate deliverables
• Strong R programming skills with extensive R Shiny experience
• Knowledge of JavaScript, HTML, CSS, C/C++/C# is a plus
• Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, study procedures)
• Good communications and problem-solving skills, ability to work well with others as well as independently

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.

For California (CA) the base pay range for this position is $129,000 to $182,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.