Principal Biostatistician

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.