Principal Biostatistician
Edwards Lifesciences · Irvine, CA +1 more
BiometricsRemoteFull-time$132k–$186kCompany career page
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Role summary
Principal Biostatistician position supporting clinical research and regulatory submissions for transcatheter cardiac therapies. Will lead statistical analyses on multiple clinical trials, collaborate with cross-functional teams, and mentor junior statisticians while contributing to process standardization.
What they're looking for
- Ph.D. in Statistics, Biostatistics, or related field with 2+ years experience
- Master's degree in Statistics, Biostatistics, or related field with 5+ years clinical trial experience
- Proficiency in R and statistical software packages
- CDISC standards knowledge (SDTM, ADaM) for regulatory-compliant analysis
- Expert knowledge of clinical trial design, statistical modeling, and regulatory guidelines (GCP, ICH, FDA, ISO)
- Strong leadership and mentoring capabilities
- Excellent written and verbal communication skills
What you'll be doing
- Lead statistical analyses for multiple clinical trials and coordinate study report documentation
- Provide biostatistical expertise for new product development and regulatory submissions (PMA, CE Mark, PMDA)
- Research and recommend novel statistical methodologies and approaches for clinical data
- Mentor junior statisticians and support resource allocation and budget planning
- Develop and standardize biostatistics SOPs and work instruction manuals
Privacy & handoff
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