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.

As the Senior Principal, Biostatistician (THV) , you will present the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.

You will make an impact by...

• Innovating as the statistical lead on multiple clinical trials, including leading the coordination of analyses for study report and other documents and provide programming and validation support of these analyses

• Collaborating with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed

• Representing Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update

• Researching and recommending novel statistical methodology and/or approaches to internal team and/or cross functional leaders, KOLs

• Providing statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team

• Compiling technical documents for internal and external audits

• Contributing to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)

• Leading the efforts of data analysis for data monitoring committee as needed

• Mentoring junior statisticians and work with management in resource allocation and budget/timeline development activities

What you'll need (Required):

• PhD in Statistics, Biostatistics, or related field , Plus 4 years of previous analytical experience in clinical trials Required OR

• Master's Degree in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials Required

• Must be able to work onsite at our company headquarters in Irvine, California

What else we look for (Preferred):

• Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses

• Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

• Excellent problem-solving, organizational, analytical and critical thinking skills

• Strong leadership skills and ability to influence change

• Ability to provide training and coaching to lower level employees

• Experience in facilitating change, including collaboration with management and executive stakeholders

• Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Ability to work successfully in a team environment, including participating and presenting at meetings, including with external representatives

• Ability to provide guidance to others on area of expertise

• 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

This position is office based at our beautiful headquarters in Irvine, California and we will support relocation cost for a qualified candidate. More details about our main campus here: https://www.edwards.com/careers/locations/irvine

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, the base pay range for this position is $190,000 to $205,000 (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.