Edwards Lifesciences Senior Biostatistician – Surgical Structural Heart in Irvine, California
This is a unique opportunity for a Senior Biostatistician to join the Surgical Structural Heart business unit to support various global clinical affairs activities. This is a fast-paced, dynamic team working on innovative medical devices. The individual in this position will have opportunities in generating evidence from various clinical trial data and Real World Data (RWD).
Essential Job Functions:
With appropriate guidance, the candidate will:
Develop Statistical Analysis Plans (SAPs) and supports the statistical execution for clinical trials
Lead the coordination of analyses for study reports and other documents and provide programming and validation support on these analyses.
Provide statistical support to the medical publications
Review protocols and contribute to protocol statistical analysis sections, generate study randomization schema when appropriate
Contribute to the results sections of the clinical study reports (CSRs) and supply statistical input for global regulatory periodic reports, submissions or in response to regulatory questions, podium presentations, and peer reviewed publications
Collaborate effectively with statistical programmers that support trials and projects
Work with cross-functional colleagues to ensure results are presented accurately and clearly
Keep abreast of new developments in statistics, device & drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
PhD in Statistics, Biostatistics or related field with internship, senior projects or thesis in Statistics, Biostatistics or related field, OR
Masters in Statistics, Biostatistics or related field with 2 years of previous analytical experience in clinical trials.
Must have sound knowledge of theoretical and applied statistics
Proficient with SAS and/or R
Knowledge of regulatory guidelines related to statistics (e.g., ICH, FDA) relevant to in Pharmaceutical/Medical Device research setting
Effective skills in communication and team collaboration
Ability to manage multiple deadlines and shifting priorities
Participated in medical publications as a statistical author
Knowledge in adaptive design (e.g. sample size re-estimation, group sequential design)
Analysis using historical control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.