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Sr Biostatistician - TMTT (Irvine, CA)

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.

This position 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.

You will make an impact by...

• 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):

• Ph.D. or equivalent in Biostatistics, or related field, including internship, senior projects, or thesis in Biostatistics or related field Required OR

• Master's Degree or equivalent in Biostatistics or related field Plus 2 years of previous analytical experience in clinical trials Required

What else we look for (Preferred):

• Training, experience and/or publication in Bayesian Methodology Preferred

• Substantial understanding and knowledge of SAS; proficiency with additional software packages such as R or S-Plus desired

• Sound knowledge of theoretical and applied statistics.

• Strong understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting.

• Effective skills in communication and team collaboration.

• Strong documentation, communication skills and interpersonal relationship management skills

• Strong problem-solving, organizational, analytical and critical thinking skills

• Ability to interact professionally with all organizational levels

• Ability to manage priorities in a fast paced environment

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $111,000 to $157,000 (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. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.