Principal Biostatistician

USA - California – Irvine

Full time

Req-49810

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.

The Principal Biostatistician will represent 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.

How you will make an impact:

• Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses

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

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

• Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team

• Compile technical documents for internal and external audits

• Contribute 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)

• Collaborate on developing case report forms and clinical database to ensure quality data collection

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

What you'll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience

What else we look for (Preferred):

• Survival analysis experience

• Proven expertise in SAS

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

• Statistical Analysis Plans (SAP).

• Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Keeps abreast of new developments in statistics and regulatory guidanceExtensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses

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

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 $132,000 - $186,000 (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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.