Principal Biostatistician
Edwards Lifesciences(1 month ago)
About this role
The Principal Biostatistician will represent Biostatistics within the Clinical Affairs organization, driving statistical design, analysis, and interpretation of clinical trial data to support product development and regulatory submissions for transcatheter heart valve therapies. The role partners with investigators, clinical teams, and regulatory authorities to generate clinical evidence demonstrating product safety and effectiveness. It contributes to global Biostatistics process development, data quality, and documentation for audits and publications.
Required Skills
- Biostatistics
- Clinical Trials
- Statistical Modeling
- Survival Analysis
- SAS
- R
- SAP
- Data Analysis
- Regulatory Knowledge
- Project Leadership
Qualifications
- Ph.D. in Statistics or Biostatistics
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