Senior Biostatistician, Cardio Trials & Regulatory Support

Edwards Lifesciences Belgium; Helena (MT); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Performance-based incentives

Benefits program

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician for our Biostatistics group in Irvine, CA. You will apply advanced biostatistical methods to support clinical research, lead analyses for multiple trials, and mentor junior statisticians in a fast-paced, data-driven environment.

Required: Ph.D. or equivalent in Statistics/ Biostatistics with 2 years (or Master's with 5 years) of clinical trial experience; expertise in R and regulatory standards; strong communication and leadership

Qualifications

• Ph.D. in Statistics/Biostatistics with 2 years clinical trial experience.
• Master's in Statistics/Biostatistics with 5 years analytical experience in clinical trials.
• Proven expertise in R and SDTM/ADaM familiarity.
• Experience with regulatory guidelines (GCP, ICH, FDA, ISO).
• Excellent communication and leadership skills.

Responsibilities

• Statistical lead on multiple clinical trials and analyses coordination.
• Collaborate with stakeholders for regulatory submissions and NPD.
• Represent Biostatistics on project teams and manage communications.
• Develop novel statistical methodologies and provide ad hoc analyses.
• Prepare technical documents for audits and SOPs/WIMs.
• Lead data analysis for Data Monitoring Committee as needed.
• Mentor junior statisticians and assist with resource planning.

Skills

R expertise

Statistical leadership

Regulatory knowledge

Leadership

Training capability

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

MS Office

Excel

Job description

Edwards Lifesciences is seeking a Principal Biostatistician for our Biostatistics group in Irvine, CA. You will apply advanced biostatistical methods to support clinical research, lead analyses for multiple trials, and mentor junior statisticians in a fast-paced, data-driven environment.

Required: Ph.D. or equivalent in Statistics/ Biostatistics with 2 years (or Master's with 5 years) of clinical trial experience; expertise in R and regulatory standards; strong communication and leadership