Edwards Lifesciences Senior Biostatistician – Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is a unique opportunity for a Senior Biostatistician to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. This is a fast-paced, dynamic team and the individual in this position will play a pivotal role in the development of new therapies and devices, from concept through to human use.
Essential Job Functions:
Develops Statistical Analysis Plans (SAPs) and leads the execution effort for assigned studies.
Develops statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.
Reviews protocols and contributes to protocol statistical analysis sections, and generates 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.
Provides 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.
Keeps 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.
PhD in Statistics/Biostatistics and 2-3 years of clinical trial experience within the medical device, pharmaceutical, biotech industries.
Masters in Statistics/Biostatistics and 5 years of clinical trial experience within the medical device, pharmaceutical, biotech industries.
Must be proficient with SAS; proficiency with additional software packages such as R or S-Plus desired
Must have sound knowledge of theoretical and applied statistics.
Must have sound 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.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Senior Biostatistician – Transcatheter Mitral & Tricuspid Therapies Location: USA-USA-California - Irvine Job Number: 013717