Principal Biostatistician

Edwards Lifesciences Gruppe; United States; On-site; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences Gruppe seeks a Principal Biostatistician to drive statistical analyses for Phase 4 trials and registries, applying causal inference and ML methods. The role supports cross-functional clinical teams and regulatory submissions in our TMTT unit.

You will mentor junior statisticians, build Python dashboards, and contribute to SOPs to standardize processes. A PhD or equivalent with extensive clinical analytics is required, with strong Python/R/SAS expertise and RWE experience.

Qualifications

• PhD or equivalent in Statistics or Biostatistics; minimum 2 years post-PhD experience.
• PhD with 2 years experience or Master with 5 years' clinical trial analytics.
• Strong programming and data analysis in clinical settings.

Responsibilities

• Lead statistical analyses for Phase 4 trials and registries.
• Collaborate on regulatory submissions (PMA, CE, PMDA) and study reports.
• Mentor junior statisticians and coordinate project timelines.
• Develop Python dashboards and contribute to SOPs (SOPs/WIMs).

Skills

Statistical leadership

Causal inference

ML & AI

Python

Cross-functional collaboration

Education

PhD in Statistics / Biostatistics or related field

Master's in Statistics / Biostatistics or related field

Tools

Python

R

SAS

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).

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.