Senior Biostatistician (TMTT)

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Job description

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.

The Senior Biostatistician participates 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.

Key Responsibilities

• 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 Requirements

• PhD in Statistics or Biostatistics with internship, senior projects or thesis in Statistics, Biostatistics OR
• Masters in Statistics or Biostatistics with 2 years of previous analytical experience in clinical trials
• Must be proficient with SAS and/or R
• Must have sound knowledge of theoretical and applied statistics
• Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical or Medical Device research setting
• Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
• Effective skills in communication and team collaboration

Preferred Qualifications

• Knowledge in adaptive design (e.g. sample size re-estimation, group sequential design, Bayesian adaptive design)
• Bayesian analysis
• Analysis using historical control
• Effective skills in communication and team collaboration.
• Ability to manage multiple deadlines and shifting priorities

E dwards 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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria , 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.