Senior Biostatistician, THV
3 days ago
As a Senior Biostatistician at Edwards Lifesciences, you will play a crucial role 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 statisticians, you will develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
Key Responsibilities- Develop and execute 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 provide statistical input for PMA submissions and regulatory questions.
- Provide independent validation of statistical content in study documents, including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities.
- Stay up-to-date with new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
- 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.
- Master's Degree or equivalent in Statistics, Biostatistics, or a related field, plus 2 years of previous analytical experience in clinical trials, or a Ph.D. or equivalent in Statistics, Biostatistics, or a related field with internship, senior projects, or a thesis in Statistics, Biostatistics, or a related field.
- Ability to work on-site on our campus in Irvine, California, for this office-based position.
- 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.
Edwards Lifesciences is a global leader in patient-focused medical innovations for cardiac and critical care. We are committed to transforming patient care with innovative devices supported by clinical evidence. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care.
What We OfferAligning 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). 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. 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.
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