Senior Principal Biostatistician

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 Principal Biostatistician 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.

How you will make an impact:

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

What you'll need (Required):