Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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.

How you will make an impact:

Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.

Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.

Review protocols and contribute to protocol statistical analysis sections, and generate 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.

Provide 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.

Keep 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.

What you'll need (Required):

Master's Degree or equivalent in Statistics, Biostatistics or related field , 2 year's experience previous analytical experience in clinical trials OR

Ph.D. or equivalent in Statistics, Biostatistics or related field internship, senior projects, or thesis in Statistics, Biostatistics or related field Required

What else we look for (Preferred):

Training or publications in Bayesian methodology

Expertise in MS Office (Word, PowerPoint, Access, Excel)

Strong written/verbal communication and relationship management skills

Up-to-date on statistical and regulatory developments

Deep knowledge of clinical trial design, statistical modeling, and data analysis

Proficient in SAS; experience with R, S-Plus

Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices

Excellent problem-solving, analytical, and critical thinking skills

Proven leadership and ability to influence change

Skilled in training/coaching and facilitating organizational change

Detail-oriented; able to manage competing priorities in fast-paced environments

Professional interaction across all levels; collaborative team player and consultant to management

For California (CA), the base pay range for this position is $119,000 to $168,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.  

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. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.