Senior Biostatistician — Clinical Trials & Evidence

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

Benefits offered by this job

Competitive salaries

Benefits programs

Job summary

Edwards Lifesciences in California seeks a Senior Biostatistician to lead statistical analyses across study lifecycles, develop SAPs, program analyses, and contribute to regulatory submissions. You will collaborate with clinical, regulatory, and cross-functional teams to ensure data quality and robust conclusions.

The role requires advanced degrees in statistics/biostatistics (PhD/MD equivalent) and experience with clinical trials, survival analysis, and regulatory guidelines.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics or related field.
• Master’s Degree or equivalent in Statistics/Biostatistics or related field with 2 years analytical experience in clinical trials.
• Ph.D./Master’s in Epidemiology or related field preferred with relevant research or internships.
• Solid knowledge of applied statistics and regulatory requirements; ability to communicate with stakeholders.
• Experience with survival and time-to-event analysis methods is preferred.
• Knowledge in Bayesian stats, causal inference, machine learning and data science is advantageous.

Responsibilities

• Develop 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.
• Author results sections of reports and provide input for PMAs and regulatory responses.
• Validate statistical content in study documents and publications.
• Interpret results and communicate findings to cross-functional teams.

Skills

Statistical analysis

SAP development

R & SAS programming

Study design

Regulatory knowledge

Collaborative skills

Education

Ph.D. in Statistics/Biostatistics

Master’s in Statistics/Biostatistics

Ph.D. in Epidemiology

Master’s in Epidemiology

Tools

SAS

R

Python

SQL

Job description

Edwards Lifesciences in California seeks a Senior Biostatistician to lead statistical analyses across study lifecycles, develop SAPs, program analyses, and contribute to regulatory submissions. You will collaborate with clinical, regulatory, and cross-functional teams to ensure data quality and robust conclusions.

The role requires advanced degrees in statistics/biostatistics (PhD/MD equivalent) and experience with clinical trials, survival analysis, and regulatory guidelines.