Senior Biostatistician, Clinical Trials Lead

Edwards Lifesciences; Irvine (CA); On-site; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analyses across clinical development, from trial designs to regulatory submissions, applying rigorous methods to endpoints and data quality. You will collaborate with investigators and regulatory authorities to drive the evidence needed to optimize patient outcomes.

The role requires a PhD in Statistics/Biostatistics with 2+ years of experience, strong SAS expertise, survival analysis familiarity, and excellent

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience
• Survival analysis experience
• Proven expertise in SAS
• Experience using other software packages (e.g., R, S-Plus)
• Statistical Analysis Plans (SAP)
• Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management
• Extensive understanding of regulatory guidelines (GCP, ICH, FDA, ISO) relevant to Pharmaceutical/Medical Device research

Responsibilities

• Statistical lead on one or more clinical trials, coordinating analyses for study reports
• Provide programming and validation support for analyses
• Collaborate with stakeholders on statistical support for new product development and regulatory submissions
• Represent Biostatistics on project teams and communicate status and timeline
• Provide statistical expertise on ad hoc data analysis requests and publications
• Compile technical documents for audits
• Contribute to standardizing Biostatistics processes and SOPs
• Collaborate on developing case report forms and clinical databases
• Lead data analysis efforts for data monitoring committees as needed

Skills

Survival analysis

SAS

R/S-Plus

SAP

MS Office

Communication

Education

PhD in Statistics/Biostatistics

Tools

SAS

R

S-Plus

Job description

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analyses across clinical development, from trial designs to regulatory submissions, applying rigorous methods to endpoints and data quality. You will collaborate with investigators and regulatory authorities to drive the evidence needed to optimize patient outcomes.

The role requires a PhD in Statistics/Biostatistics with 2+ years of experience, strong SAS expertise, survival analysis familiarity, and excellent