Current jobs related to Senior Biostatistician, Transcatheter Heart Valve Specialist - Irvine, California - Edwards Lifesciences
-
Senior Biostatistician, THV
1 month ago
Irvine, California, United States Edwards Lifesciences Full timeAbout the RoleAs 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...
-
Senior Biostatistician, THV
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Statistical ExpertiseAortic stenosis affects millions worldwide, yet often remains under-diagnosed and undertreated. Edwards' pioneering work in transcatheter aortic heart valve replacement (TAVR) has revolutionized patient care. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical...
-
Senior Biostatistician, THV
3 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesAortic stenosis affects millions globally, yet it often remains under-diagnosed and undertreated. Edwards' pioneering work in transcatheter aortic heart valve replacement (TAVR) has revolutionized patient care by offering heart valve replacement without open heart surgery. Our Transcatheter Heart Valve (THV)...
-
Senior Biostatistician, THV
3 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesAortic stenosis affects millions globally, yet it often remains under-diagnosed and undertreated. Edwards' pioneering work in transcatheter aortic heart valve replacement (TAVR) has revolutionized patient care by offering heart valve replacement without open heart surgery. Our Transcatheter Heart Valve (THV)...
-
Senior Biostatistician
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeSenior Biostatistician - TMTTPatients with complex heart valve conditions require innovative solutions. Edwards Lifesciences' Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is pioneering a portfolio of technologies to address unmet clinical needs. We're driven to help patients live longer, healthier lives.This role participates in planning...
-
Senior Biostatistician
1 month ago
Irvine, California, United States Edwards Lifesciences Full timeSenior Biostatistician - TMTTEdwards Lifesciences is seeking a highly skilled Senior Biostatistician to join our Transcatheter Mitral and Tricuspid Therapies (TMTT) team. As a key member of our team, you will play a critical role in the planning and execution of statistical tasks for assigned studies within a project.Key Responsibilities:Develop Statistical...
-
Heart Valve Sewing Specialist
4 weeks ago
Irvine, California, United States Kimco Staffing Services Full timeJob Opportunity in Irvine, CAWe are seeking a skilled Heart Valve Sewing professional to join our team in Irvine, CA. As a key member of our team, you will be responsible for performing detailed tissue inspections, sewing heart valves under a microscope, and operating basic manufacturing and testing equipment.Key Responsibilities:Conduct thorough tissue...
-
Product Manager
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesInnovation is at the heart of everything we do at Edwards Lifesciences. As a Product Manager, you will play a critical role in shaping the future of cardiovascular care by developing and launching innovative medical devices that transform patient lives.Key Responsibilities:Drive product design requirements...
-
Senior Clinical Data Manager
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesImagine how your expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating...
-
Senior Clinical Data Manager
3 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesImagine how your expertise can change a patient's life. At Edwards Lifesciences, we generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives.As part of our Clinical Affairs team, you'll hone your scientific curiosity and...
-
Senior Director of Marketing Strategy
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeAbout Edwards LifesciencesEdwards Lifesciences is a global leader in the development, manufacturing, and marketing of innovative medical solutions for the treatment of cardiovascular disease. Our mission is to help patients live longer, healthier lives.Job SummaryWe are seeking a highly experienced Senior Director of Marketing to lead our Transcatheter Heart...
-
Senior Clinical Data Manager
2 weeks ago
Irvine, California, United States Edwards Lifesciences Corp Full timeTransform Patient Care with Edwards Lifesciences CorpImagine how your expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for...
-
LVN - Heart Valve Clinic Professional
4 weeks ago
Irvine, California, United States Hoag Memorial Hospital Presbyterian Full timeJob SummaryWe are seeking a skilled LVN to join our Heart Valve Clinic team. As a Vocational Nurse, you will provide high-quality patient care under the direction of a registered nurse, ensuring the delivery of timely, safe, and quality care.ResponsibilitiesAssess, plan, implement, and evaluate patient care, following regulatory standards and the Vocational...
-
MBA Summer Associate Program
1 month ago
Irvine, California, United States Edwards Lifesciences Full timeAbout Edwards LifesciencesEdwards Lifesciences is a global leader in the development, manufacturing, and marketing of innovative medical technologies for the treatment of cardiovascular disease. Our mission is to help patients live longer, healthier lives.Job SummaryWe are seeking highly motivated and talented MBA students to join our 2025 Summer Associate...
-
Senior Director of Marketing Strategy
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeAbout Edwards LifesciencesEdwards Lifesciences is a global leader in the development, manufacturing, and marketing of innovative medical solutions for the treatment of cardiovascular disease. Our mission is to help patients live longer, healthier lives.Job SummaryWe are seeking a highly experienced Senior Director of Marketing to lead our Transcatheter Heart...
-
Operations Manager
2 weeks ago
Irvine, California, United States BRIDGEMED SOLUTIONS INC Full timeJob Title: Operations ManagerBridgeMed Solutions Inc is seeking a skilled Operations Manager to join our team. As a key member of our organization, you will be responsible for providing engineering support for products from design through commercialization.Responsibilities:Design and develop medical devices and procedures using engineering principles and...
-
Catheterization Lab Registered Nurse
1 week ago
Irvine, California, United States Fifth Commandment Healthcare Staffing Full timeJob Title: Catheterization Lab Registered NurseAbout the Job:Fifth Commandment Healthcare Staffing is seeking a skilled Registered Nurse to join our team in the Catheterization Lab department. Job Summary:We are looking for a highly experienced Registered Nurse with a minimum of 5 years of experience in a Cath Lab, ICU, or ER setting. The ideal candidate...
-
Senior Manufacturing Engineer
2 weeks ago
Irvine, California, United States TalentBurst Full timeJob Summary:The Senior Manufacturing Engineer will be responsible for applying engineering theory and principles to problems of industrial layout or manufacturing production. This role will provide a direct chance to contribute to the creation of new heart valves, a novel product that will be the first of its kind.Key Responsibilities: Execute production...
-
Senior Manufacturing Engineer
2 weeks ago
Irvine, California, United States TalentBurst Full timeJob Title: Senior Manufacturing EngineerAt TalentBurst, we are seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for applying engineering theory and principles to problems of industrial layout or manufacturing production.Key Responsibilities:Execute production builds both...
-
Clinical Affairs Manager
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeWe're seeking a highly skilled Clinical Affairs Manager to join our team at Edwards Lifesciences. As a key member of our Clinical Affairs team, you'll play a critical role in driving the evidence needed to optimize patient outcomes.In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory...
Senior Biostatistician, Transcatheter Heart Valve Specialist
2 months ago
Edwards Lifesciences is a leading global medical technology company that develops and manufactures innovative solutions for cardiovascular and critical care procedures. Our mission is to help patients live longer, healthier lives.
Job SummaryWe are seeking a highly skilled Senior Biostatistician to join our Transcatheter Heart Valve (THV) business unit. As a key member of our team, you will play a critical role in the planning and execution of statistical tasks for assigned studies, ensuring the accuracy and reliability of our clinical data.
Key Responsibilities- Develop and lead the execution of Statistical Analysis Plans (SAPs) for assigned studies, ensuring compliance with regulatory guidelines and company standards.
- Design and implement statistical programs to ensure the accuracy of planned and completed analyses, including exploratory analyses.
- Contribute to protocol statistical analysis sections and generate study randomization schemes as needed.
- Author results sections of clinical study reports and provide statistical input for regulatory submissions and responses.
- Validate the 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 collaborate with management and other team members on study status and timeline updates.
- Participate in developing case report forms and clinical databases 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
- Ph.D. or equivalent in Statistics, Biostatistics, or a related field, with internship, senior projects, or thesis experience in Statistics, Biostatistics, or a related field.
- Ability to work on-site at our campus in Irvine, California.
- 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, such as GCP and FDA, as they apply to a Pharmaceutical/Medical Device research setting.
- Ability to act professionally and utilize skills in communication and team collaboration effectively.
- Experience using other software packages, such as R or S-Plus.
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, such as qualifications, education, and prior experience.
Equal Opportunity EmployerEdwards Lifesciences is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.
COVID Vaccination RequirementEdwards Lifesciences 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.
