Principal Biostatistician Job at Edwards Lifesciences, Irvine, CA

  • Edwards Lifesciences
  • Irvine, CA

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation: $132,000–$186,000 base

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