Principal Biostatistician

Edwards Lifesciences; Irvine (CA); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Benefits programs

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to drive machine learning and AI-driven analytics for clinical and real-world evidence projects. You will develop Python-based dashboards, apply causal inference methods, and guide analyses for Phase 4 studies and registries to support cross-functional teams.

You will mentor junior statisticians, contribute to SOPs and WIMs, and collaborate with stakeholders on regulatory submissions while ensuring data integrity and regulatory

Qualifications

• PhD or equivalent in Statistics/Biostatistics or related field.
• 2 years’ experience in a statistical role within clinical trials or related field.

Responsibilities

• Lead statistical analyses for multiple clinical trials and support study reports.
• Provide statistical expertise for NPD and regulatory submissions (PMAs, CE marks, PMDA).
• Coordinate project status updates with management and teams.
• Develop data-driven solutions and contribute to audits and SOPs.

Skills

Machine learning

AI agent development

Python

R

SAS

Clinical data

Real-world evidence

Survival analysis

Leadership

Regulatory guidance

Education

PhD or equivalent in Statistics/Biostatistics

Master's Degree in Statistics/Biostatistics

Tools

Microsoft Office

Job description

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. 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 focus on machine learning, AI agent development, and Python-based dashboards supporting clinical and real-world evidence applications. The role will apply causal inference methodologies to Phase 4 studies and registries and develop data-driven solutions for cross-functional clinical teams.

How you will make an impact:

• Statistical lead on multiple 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 multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
• Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
• Research and recommend novel statistical methodology and/or approaches Provide statistical expertise and guidance to internal and external stakeholders 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)
• Lead the efforts of data analysis for data monitoring committee as needed
• Mentor Junior statisticians and work with management in resource allocation and budget/timeline development activities

What you'll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience of experience
• Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years’ experience of previous analytical experience in clinical trials

What else we look for (Preferred):

• Experience with machine learning and AI agent development
• Experience developing machine learning dashboards
• Advanced proficiency in Python
• Proficiency in R and SAS
• Deep familiarity with clinical data and/or real-world evidence (RWE)
• Experience applying machine learning to clinical data
• Expertise in causal inference methodologies for real-world evidence
• Experience with survival analysis
• Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
• 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 guidance
• Extensive 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

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 $132,000 to $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.