Principal Biostatistician

Edwards Lifesciences • Irvine, CA

3d

About The Position

The Principal Biostatistician is part of the Medical Affairs team and supports the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit. The role focuses on machine learning, AI agent development, and Python-based dashboards for clinical and real-world evidence applications. It applies causal inference methodologies to Phase 4 studies and registries and develops data-driven solutions for cross-functional clinical teams.

The role provides statistical leadership across clinical trials, supports analyses and related study documentation, and contributes statistical expertise to product development and regulatory submissions. It also advises internal and external stakeholders, supports data monitoring committee analyses, advances Biostatistics processes, and mentors junior statisticians.

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.
• Extensive understanding of statistical methodologies related to clinical trial design, statistical modeling, and data analysis.
• Excellent written and verbal communication and interpersonal skills, including negotiation and relationship management.
• Strong 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.
• Ability to facilitate change in collaboration with management and executive stakeholders.

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 (RWE).
• Experience applying machine learning to clinical data.
• Expertise in causal inference methodologies for real-world evidence.
• Experience with survival analysis.
• Proficiency in MS Office Suite, including Word, PowerPoint, Access, and Excel.
• Keeps abreast of new statistical developments and regulatory guidance.
• Extensive knowledge of regulatory guidelines relevant to pharmaceutical or medical device research, such as GCP, ICH, FDA, and ISO.

Responsibilities

• Serve as statistical lead on multiple clinical trials and coordinate analyses for study reports and other documents, including programming and validation support.
• Provide statistical expertise to stakeholders supporting new product development, regulatory submissions, and other regulatory documents.
• Represent Biostatistics on project and study teams and communicate project status and timeline updates with management and team members.
• Research and recommend novel statistical methodologies and approaches.
• Provide statistical guidance for ad hoc data analysis requests and publication and presentation efforts.
• Compile technical documents for internal and external audits.
• Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including 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 and 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