Senior Biostatistician

Edwards Lifesciences • Irvine, CA

3d • $119,000 - $168,000

About The Position

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Biostatistician participates 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 statistician. How you will make an impact: Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies. Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses. Review protocols and contribute to protocol statistical analysis sections, and generate 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. Provide 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. Keep 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.

Requirements

• Master's Degree or equivalent in Statistics, Biostatistics or related field , 2 year's experience previous analytical experience in clinical trials OR Ph.D. or equivalent in Statistics, Biostatistics or related field internship, senior projects, or thesis in Statistics, Biostatistics or related field Required

Nice To Haves

• Training or publications in Bayesian methodology
• Expertise in MS Office (Word, PowerPoint, Access, Excel)
• Strong written/verbal communication and relationship management skills
• Up-to-date on statistical and regulatory developments
• Deep knowledge of clinical trial design, statistical modeling, and data analysis
• Proficient in SAS; experience with R, S-Plus
• Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices
• Excellent problem-solving, analytical, and critical thinking skills
• Proven leadership and ability to influence change
• Skilled in training/coaching and facilitating organizational change
• Detail-oriented; able to manage competing priorities in fast-paced environments
• Professional interaction across all levels; collaborative team player and consultant to management

Responsibilities

• Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
• Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.
• Review protocols and contribute to protocol statistical analysis sections, and generate 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.
• Provide 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.
• Keep 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level