Senior Biostatistician

Edwards Lifesciences • Irvine, CA

4d • $119,000 - $168,000

About The Position

The Senior Biostatistician supports clinical studies throughout the study lifecycle by applying statistical expertise. The role develops and executes Statistical Analysis Plans (SAPs), performs and validates statistical analyses and programming, contributes to protocols and randomization, and supports clinical study reports, publications, regulatory submissions, and exploratory analyses for clinical and business objectives. The position works with clinical, medical, regulatory, and other cross-functional stakeholders to help generate evidence on the effectiveness and safety of transcatheter heart valve technologies.

Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or a related field, with an internship, senior project, or thesis in Statistics, Biostatistics, or a related field; alternatively, a master's degree or equivalent in Statistics, Biostatistics, or a related field and 2 years of previous analytical experience in clinical trials.
• Solid knowledge of applied statistics and regulatory requirements.
• Effective communication and collaboration skills.
• Demonstrated knowledge and experience with survival and time-to-event analysis methods.
• Strong written and verbal communication skills, including the ability to explain statistical concepts and results to technical and non-technical stakeholders.
• Ability to work independently, take ownership of statistical deliverables, and collaborate effectively within cross-functional teams.
• Sound understanding of regulatory guidelines, such as GCP and FDA guidance, as applied to pharmaceutical and medical device research settings.

Nice To Haves

• Ph.D. in Epidemiology or a related field, with relevant research, internship, thesis, or other applied experience.
• Master’s degree in Epidemiology or a related field and at least 2 years of analytical experience, preferably in clinical trials.
• Experience with real-world data (RWD) or real-world evidence (RWE).
• Knowledge or applied experience in Bayesian statistical methods.
• Knowledge or applied experience in causal inference methods.
• Experience with machine learning, data science, or other emerging quantitative methods.

Responsibilities

• Develop Statistical Analysis Plans (SAPs) and lead their execution for assigned studies.
• Develop statistical programs as needed to ensure the accuracy of planned and completed analyses.
• Review protocols, contribute to statistical analysis sections, and generate study randomization schemes when appropriate.
• Author results sections of clinical study reports and provide statistical input for PMA submissions and responses to regulatory questions.
• Independently validate statistical content in study documents, including randomization schemes, reports, briefing documents, patient brochures, publications, and other materials delivered externally.
• Interpret statistical results and communicate findings, assumptions, and limitations to clinical, medical, regulatory, and other cross-functional stakeholders.
• Keep current with developments in statistics, clinical research, regulatory guidance, and emerging statistical methodologies through literature review and attendance at workshops and professional meetings.
• Represent Biostatistics on study teams and coordinate with management and team members on study status and timeline updates.
• Manage statistical deliverables, priorities, and timelines for assigned studies, and proactively communicate status, risks, and issues.
• Participate in developing case report forms and the clinical database, and support data-cleaning activities to ensure high-quality data collection.

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: Senior
• Education Level: Ph.D. or professional degree