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Lead Biostatistician for Heart Valve Innovations

2 months ago

Irvine, California, United States Edwards Lifesciences Full time

Senior Biostatistician Role

Edwards Lifesciences, a pioneer in the transcatheter heart valve replacement sector, is committed to enhancing patient care through cutting-edge medical technologies. We are seeking a Senior Biostatistician to contribute to our mission.

Key Responsibilities:

  • Formulate and oversee Statistical Analysis Plans (SAPs) for designated clinical studies.
  • Assess study protocols and enhance the statistical analysis components.
  • Conduct independent evaluations of statistical content in clinical documentation.
  • Keep abreast of advancements in statistical methodologies and regulatory frameworks.
  • Act as a representative for Biostatistics within study teams, providing updates on project progress.

Essential Qualifications:

  • Master's Degree in Statistics, Biostatistics, or a related discipline, complemented by 2 years of analytical experience in clinical research.
  • Willingness to work on-site.

Desirable Qualifications:

  • In-depth understanding of both theoretical and practical statistics.
  • Expertise in SAS and familiarity with additional software such as R or S-Plus.
  • Prior knowledge of regulatory standards in pharmaceutical or medical device research.
  • Strong communication and collaborative skills.

Edwards Lifesciences provides competitive compensation, performance-driven incentives, and a comprehensive benefits package tailored to individual needs. We are an Equal Opportunity/Affirmative Action employer dedicated to safeguarding the health of patients and healthcare professionals. Compliance with COVID-19 vaccination protocols is mandatory for roles involving patient interaction.