Senior Biostatistician, THV

2 weeks ago

Irvine, California, United States Edwards Lifesciences Full time
Transform Patient Care with Edwards Lifesciences

Aortic stenosis affects millions globally, yet it often remains under-diagnosed and undertreated. Edwards' pioneering work in transcatheter aortic heart valve replacement (TAVR) has revolutionized patient care by offering heart valve replacement without open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.

Key Responsibilities
  • Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies
  • Develop statistical programs to ensure the accuracy of planned and completed analyses or exploratory analyses
  • Review protocols and contribute to protocol statistical analysis sections and generate study randomization schemes when appropriate
  • Author results sections of clinical study reports and supply statistical input for PMA submissions and regulatory questions
  • Provide independent validation of statistical content in study documents
  • Stay abreast of new developments in statistics, drug development, and regulatory guidance
  • Represent Biostatistics in study teams and work with management and other team members regarding study status and timeline updates
  • Participate in developing case report forms and clinical databases and data cleaning to ensure quality data collection
Requirements
  • Master's Degree or equivalent in Statistics, Biostatistics, or related field with 2 years of analytical experience in clinical trials or Ph.D. or equivalent in Statistics, Biostatistics, or related field with internship, senior projects, or thesis in Statistics, Biostatistics, or related field
  • Ability to work on-site on our campus in Irvine, California
Preferred Qualifications
  • Strong knowledge of theoretical and applied statistics
  • Proven expertise in SAS
  • Proven proficiency with additional software packages such as R or S-Plus
  • Previous understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting
  • Ability to act professionally and utilize skills in communication and team collaboration effectively
What We Offer

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $113,000 to $155,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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

COVID Vaccination Requirement: Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.

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