Sr Biostatistician

Senior Biostatistician, Transcatheter Heart Valve
This Sr Biostatistician 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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under[1]treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for 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. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
You will make an impact by...

• Developing Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies
• Developing statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.
• Reviewing protocols and contribute to protocol statistical analysis sections, and generate study randomization scheme when appropriate.
• Authoring results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions.
• Providing 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.
• Staying abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
• Representing Biostatistics in study team and work with management and other team members regarding study status and timeline update.
• Participating 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 Plus 2 years previous analytical experience in clinical trials Required OR
• Ph.D. or equivalent in Statistics, Biostatistics or related field; internship, senior projects, or thesis in Statistics, Biostatistics or related field Required
• Ability to work on-site on our campus in Irvine, California for this office based position

What else we look for (Preferred):

• Strong knowledge of theoretical and applied statistics
• Proven expertise in SAS
• Proven proficiency with additional software packages such as R or S-Plus desired
• Previous understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting.
• Ability to act professional and utilize skills in communication and team collaboration effectively
• Experience using other software packages (e.g., R, S-Plus)
• 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 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.