Senior Principal Biostatistician (Epidemiology

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 limitedtreatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldlypursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s ourdriving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Principal Biostatistician (Epidemiology) will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.

• Lead end-to-end evidence strategies, designing observational studies, interventional trials, and real-world evidence (RWE) programs to support pipeline and on-market products

• Build economic models (cost-effectiveness, budget impact) to clearly communicate the clinical, and economic value of Edwards products

• Statistical lead on multiple clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses

• Collaborate with cross-functional partners and external analysts in the execution of studies and implementation of field-based, customer-focused initiatives and partnerships (e.g., models, presentations, publications, formulary/regulatory dossiers).

• Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update

• Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team

• Research and recommend novel statistical methodology and/or approaches

• Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)

• Lead the efforts of data analysis for data monitoring committee as needed

• Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities

• Bachelor's Degree in Statistics, Biostatistics, or related field, 8 years of previous analytical experience in clinical trials or

• Master's Degree or equivalent in Statistics, Biostatistics, or related field, 7 years of previous analytical experience in clinical trials or

• Ph.D. or equivalent in Statistics, Biostatistics, or related field , 4 years of experience

• Medical device industry experience strongly preferred, including statistical support for clinical studies, real-world evidence, and regulatory submissions.

• Deep knowledge of outcomes research and RWE methodologies (study design, statistics, data sources, and implementation)

• Deep knowledge of observational study methods, causal inference, economic model (cost-effectiveness), epidemiology

• Proven experience managing vendors, budgets, and building productive partnerships with internal stakeholders and external experts/KOLs

• Demonstrated leadership in matrixed environments, including the ability to direct work across functions to deliver shared objectives

• Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel

• Excellent written and verbal communication…