Senior Biostatistician

Edwards Lifesciences Gruppe; Irvine, Des Moines (CA, IA); On-site; USD 119,000 - 168,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Biostatistician to support clinical studies from SAP development to statistical analyses and reporting. You will collaborate with clinicians, regulatory teams, and cross-functional partners to ensure robust statistical support across the study lifecycle.

The role requires a PhD or equivalent in Statistics/Biostatistics (or related) and experience with regulatory guidance (GCP/FDA).

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field.
• Master's Degree or equivalent in Statistics, Biostatistics or related field, 2 years analytical experience in clinical trials.
• Knowledge of regulatory guidelines (GCP, FDA) and strong communication skills.

Responsibilities

• Develop Statistical Analysis Plans (SAPs) and lead execution for assigned studies.
• Develop statistical programs to ensure accuracy of analyses.
• Review protocols and contribute to statistical sections; generate randomization schemes when appropriate.
• Author results sections of clinical study reports and contribute to PMA submissions.
• Provide independent validation of statistical content in study documents and other materials.
• Interpret results and communicate findings to cross-functional stakeholders.
• Keep abreast of new developments in statistics and regulatory guidance.
• Represent Biostatistics on study teams and manage deliverables and timelines.
• Participate in developing case report forms and data support data cleaning activities.

Skills

Statistical analysis

Data interpretation

Communication skills

Collaboration

Regulatory knowledge

Education

PhD in Statistics/Biostatistics or related field

Master's in Statistics/Biostatistics or related field

Tools

R/SAS

SAPs development

Survival analysis

Job description

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Biostatistician will support clinical studies by applying statistical expertise throughout the study lifecycle, including developing and executing Statistical Analysis Plans (SAPs), performing and validating statistical analyses and programming, contributing to protocols and randomization, and supporting clinical study reports, publications, submissions, exploratory analysis for clinical and business objectives.

How you will make an impact:

• Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
• Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses.
• Review protocols and 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.
• Provide independent validation of statistical content in study documents including randomization schemes, reports, briefing documents, patient brochures, publications, and other content delivered to external entities.
• Interpret statistical results and clearly communicate findings, assumptions, and limitations to clinical, medical, regulatory, and other cross-functional stakeholders.
• Keep abreast of new 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 work with management and other team members regarding study status and timeline updates.
• Independently manage statistical deliverables, priorities, and timelines for assigned studies, and proactively communicate study status, risks, and issues.
• Participate in the developing case report forms and clinical database and data support data cleaning activities to ensure high-quality data collection.

What you'll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, internship, senior projects, or thesis in Statistics, Biostatistics or related field.
• Master's Degree or equivalent in Statistics, Biostatistics or related field, 2 years previous analytical experience in clinical trials.

What else we look for (Preferred):

• Ph.D. in Epidemiology or related field, with relevant research, internships, thesis or other applied experience.
• Master's degree in Epidemiology or related field with at least 2 years of analytical experience, preferable in clinical trials.
• Must have solid knowledge of applied statistics and regulatory requirements, as well as 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 both 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 (e.g., GCP, FDA) as they apply to pharmaceutical and medical device research settings.
• 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.

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, the base pay range for this position is $119,000 - $168,000 (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.