Principal Biostatistician

Edwards Lifesciences • Irvine, CA

4d • $132,000 - $186,000

About The Position

The Principal Biostatistician is part of the Medical Affairs team and supports clinical and real-world evidence applications, with a focus on machine learning, AI agent development, and Python-based dashboards. The role applies causal inference methodologies to Phase 4 studies and registries and develops data-driven solutions for cross-functional clinical teams. The position also provides statistical leadership across clinical trials, product development, and regulatory submissions.

Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or a related field, with 2 years of experience.
• Alternatively, a master's degree or equivalent in Statistics, Biostatistics, or a related field, with 5 years of previous analytical experience in clinical trials.

Nice To Haves

• 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.
• Experience applying machine learning to clinical data.
• Expertise in causal inference methodologies for real-world evidence.
• Experience with survival analysis.
• Extensive understanding of 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 and interpersonal relationship skills, including negotiating and relationship management skills.
• Keeps abreast of new developments in statistics and regulatory guidance.
• Extensive understanding of regulatory guidelines such as GCP, ICH, FDA, and ISO relevant to pharmaceutical or medical device research.
• 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 facilitating change, including collaborating with management and executive stakeholders.

Responsibilities

• Serve as statistical lead on multiple clinical trials, coordinate analyses for study reports and other documents, and provide programming and validation support.
• Collaborate with core stakeholders to provide statistical expertise for new product development and regulatory submissions, including PMA, CE Mark, and PMDA submissions.
• Represent Biostatistics on project and study teams and communicate project or study status and timeline updates to management and team members.
• Research and recommend novel statistical methodologies and approaches.
• Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication or presentation efforts.
• Compile technical documents for internal and external audits.
• Contribute to improving, standardizing, and globalizing Biostatistics processes and procedures, including developing SOPs and Work Instruction Manuals.
• Lead data analysis efforts for data monitoring committees as needed.
• Mentor junior statisticians and work with management on resource allocation, budget, and timeline development.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree