Principal Biostatistician Job at Edwards Lifesciences, Irvine, CA

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  • Edwards Lifesciences
  • Irvine, CA

Job Description

Edwards Lifesciences seeks a Principal Biostatistician to lead statistical efforts on clinical trials and real-world evidence studies for transcatheter cardiac therapies. The role emphasizes machine learning, AI development, causal inference methodologies, and cross-functional collaboration to support regulatory submissions and clinical evidence generation.

Responsibilities

  • Lead statistical analyses for multiple clinical trials and coordinate study report generation with programming validation
  • Collaborate with stakeholders to provide statistical expertise for new product development and regulatory submissions (PMA, CE Mark, PMDA)
  • Research and recommend novel statistical methodologies and approaches for clinical data applications
  • Mentor junior statisticians and contribute to development of biostatistics SOPs and work instructions
  • Develop machine learning dashboards and data-driven solutions supporting clinical teams

Requirements

  • Ph.D. in Statistics, Biostatistics, or related field with 2+ years of experience
  • Master's degree in Statistics, Biostatistics, or related field with 5+ years of clinical trial analytical experience
  • Experience with machine learning and AI agent development
  • Advanced Python proficiency and proficiency in R and SAS
  • Knowledge of causal inference methodologies and real-world evidence applications
  • Understanding of regulatory guidelines (GCP, ICH, FDA, ISO) in pharmaceutical/medical device settings
  • Strong leadership, communication, and mentoring capabilities

Compensation: $132,000–$186,000 base

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