This is a unique opportunity for a biostatistician professional to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. This is a fast-paced, dynamic team and the individual in this position will play a pivotal role in the development of new therapies and devices, from concept through to human use.

As a Senior Biostatistician, you participate in the planning and execution of statistical tasks for assigned studies within a project under high level guidance from management or more senior level project statistician.

What You’ll Do

  • Develops Statistical Analysis Plans (SAPs) and leads the execution effort for assigned studies.
  • Develops statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses
  • Reviews protocols and contributes to protocol statistical analysis sections, and generates study randomization scheme when appropriate
  • Author results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions
  • Provides independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities
  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
  • Represent Biostatistics in study team and work with management and other team members regarding study status and timeline update
  • Participate in developing case report forms and clinical database and data cleaning to ensure quality data collection

    • Minimum Qualifications

  • PhD in Biostatistics or Statistics with internship, senior projects or thesis in Biostatistics or Statistics OR
  • Must be proficient with R, Python and SAS

    • Preferred Qualifications

  • Knowledge in adaptive design ( sample size re-estimation, group sequential design, Bayesian adaptive design)
  • Bayesian analysis
  • Analysis using historical control

    • General Expectations

  • Demonstrated understanding in the areas of machine learning, big data and AI
  • Must have sound knowledge of theoretical and applied statistics
  • Must have sound understanding of regulatory guidelines (, GCP, FDA) as they apply to a Pharmaceutical and/or Medical Device research setting
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
  • Effective skills in communication and team collaboration
  • Effective skills in communication and team collaboration
  • Ability to manage multiple deadlines and shifting priorities

    • Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

    Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.