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.

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.

You will make an impact by...

• Overall participation in the planning and execution of statistical tasks for assigned studies within a project under high level guidance from management or more senior level project statistician.

• Development of Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.

• Development of statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.

• Review protocols and contribute to protocol statistical analysis sections and generate study randomization scheme when appropriate.

• Author results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions.

• Provide independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities.

• Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

• Represent Biostatistics in study team and work with management and other team members regarding study status and timeline update.

• Participate in developing case report forms and clinical database and data cleaning to ensure quality data collection.

What you'll need (Required):

• Ph.D. in Statistics, Biostatistics, or related majors, including field internship, senior projects, or thesis in Statistics, Biostatistics or related 

• Master's Degree in Statistics, Biostatistics, or related majors, plus 2 years of work experience in industry

• Qualified candidates must be able to work onsite at our main campus in Irvine, California. We will support relocation costs for a qualified candidate who currently resides 50 miles or more from our Irvine main campus.

What else we look for (Preferred):

• Proficiency in SAS; proficiency with additional software packages such as R or S-Plus desired

• Must have sound knowledge of theoretical and applied statistics.

• Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting.

• Effective skills in communication and team collaboration.

• Proven expertise in SAS

• Experience using other software packages (e.g., R, S-Plus)

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $116,000 to $164,000 (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.