Senior Biostatistician

Edwards Lifesciences • Irvine, CA

7d • $119,000 - $168,000

About The Position

Imagine how your ideas and 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 data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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 years' 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

Nice To Haves

• Survival analysis experience
• Proven expertise in SAS
• Experience using other software packages (e.g., R, S-Plus)
• Statistical Analysis Plans (SAP)
• Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Keeps abreast of new developments in statistics and regulatory guidance
• Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

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.

Benefits

• Aligning our overall business objectives with performance, 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.

What This Job Offers

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