Edwards Lifesciences Veterans Jobs

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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.

Education/Experience:

  • 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.

Required Skills:

  • 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

Desired Skills:

  • Participated in medical publications as a statistical author

  • Knowledge in adaptive design (e.g. sample size re-estimation, group sequential design)

  • Bayesian analysis

  • 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.

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