Senior Principal Biostatistician - Remote Impact & RWE

Edwards Lifesciences; Montpelier (VT); Remote; USD 151,000 - 215,000; Full time

Benefits offered by this job

Benefits programs

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Senior Principal Biostatistician to lead end-to-end evidence strategies across clinical development, observational studies, and real-world evidence programs. You will build economic models to communicate value and serve as statistical lead on multiple trials, coordinating analyses and providing programming support.

The role requires advanced degrees in statistics with substantial experience in clinical research, regulatory submissions, and

Qualifications

• Bachelor's Degree in Statistics, Biostatistics, or related field; 8 years of analytical experience in clinical trials.
• Master's Degree or equivalent in Statistics, Biostatistics, or related field; 7 years of analytical experience in clinical trials.
• Ph.D. or equivalent in Statistics, Biostatistics, or related field; 4 years of experience.

Responsibilities

• Lead end-to-end evidence strategies, designing observational studies, interventional trials, and real-world evidence programs.
• Build economic models (cost-effectiveness, budget impact) to communicate clinical and economic value.
• Statistical lead on multiple clinical trials and coordination of analyses for study reports.
• Provide programming and validation support of analyses and collaborate with cross-functional partners.
• Represent Biostatistics on project teams and communicate timelines and status.
• Provide statistical expertise for ad hoc data analyses and publications.
• Research and recommend novel statistical methodologies or approaches.
• Contribute to SOPs and work instructions to standardize Biostatistics processes.
• Lead data analysis efforts for data monitoring committees as needed.
• Mentor junior statisticians and assist with resource/budget planning.

Skills

SAS

R

Statistical modeling

Clinical trials

Budget management

Education

Bachelor's Degree in Statistics/Biostatistics

Master's Degree in Statistics/Biostatistics

Ph.D. in Statistics/Biostatistics

Tools

SAS

R

MS Office

Excel

PowerPoint

Job description

Edwards Lifesciences in Irvine, CA, seeks a Senior Principal Biostatistician to lead end-to-end evidence strategies across clinical development, observational studies, and real-world evidence programs. You will build economic models to communicate value and serve as statistical lead on multiple trials, coordinating analyses and providing programming support.

The role requires advanced degrees in statistics with substantial experience in clinical research, regulatory submissions, and