Senior Biostatistician

Patients are at the heart of everything we do. As part of our Medical Affairs team youll 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 limitedtreatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldlypursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its ourdriving 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 youll need (Required):

• Masters Degree or equivalent in Statistics Biostatistics or related field 2 years 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 $119000 to $168000 (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.