Principal Biostatistician
Edwards Lifesciences
Summary
The Principal Biostatistician will apply advanced biostatistical expertise to support clinical research and inform strategic decision-making through hands-on statistical analysis of clinical data. Serve as a technical contributor with direct responsibility for implementing statistical methodologies, interpreting results, and delivering high-quality analyses in a highly data-driven environment.
Job description
How you will make an impact:
- 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 core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
- Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
- Research and recommend novel statistical methodology and/or approaches
- 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
- Compile technical documents for internal and external audits
- 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):
- Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience
- Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years' experience of previous analytical experience in clinical trials Required OR
What else we look for (Preferred):
- Proven expertise in R; experience with additional statistical software packages (e.g., S-PLUS or other analytics tools)
- Experience with CDISC standards (e.g., SDTM and ADaM), demonstrating expertise in clinical trial data structures, data standardization, and regulatory-compliant statistical analysis
- Validate statistical outputs and review Tables, Listings, and Figures (TLFs); develop TLF shells and contribute to the preparation of study-related documentation
- 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 with ability to drive achievement of objectives
- Keeps abreast of new developments in statistics and regulatory guidance
- Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
- Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device
- Excellent problem-solving, organizational, analytical and critical thinking skills
- Strong leadership skills and ability to influence change
- Ability to provide training and coaching to lower-level employees
- Experience in facilitating change, including collaboration with management and executive stakeholders
Requirements
- Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience
- Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years' experience of previous analytical experience in clinical trials Required OR
- Proven expertise in R; experience with additional statistical software packages (e.g., S-PLUS or other analytics tools)
- Experience with CDISC standards (e.g., SDTM and ADaM), demonstrating expertise in clinical trial data structures, data standardization, and regulatory-compliant statistical analysis
- Validate statistical outputs and review Tables, Listings, and Figures (TLFs); develop TLF shells and contribute to the preparation of study-related documentation
- 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 with ability to drive achievement of objectives
- Keeps abreast of new developments in statistics and regulatory guidance
- Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
- Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device
- Excellent problem-solving, organizational, analytical and critical thinking skills
- Strong leadership skills and ability to influence change
- Ability to provide training and coaching to lower-level employees
- Experience in facilitating change, including collaboration with management and executive stakeholders
Benefits
- Competitive salaries
- Performance-based incentives
- Wide variety of benefits programs
Company overview
Edwards Lifesciences (NYSE: EW) is the leading global structural heart innovation company, driven by a passion to improve patient lives. Founded in 1958 and headquartered in Irvine, California, the company specializes in developing breakthrough technologies for cardiovascular diseases. As a pioneer in the medical device industry, Edwards focuses on transcatheter heart valves, surgical heart valves, hemodynamic monitoring systems, and vascular solutions. The company's patient-focused culture inspires its 16,000+ employees worldwide to deliver life-changing innovations that address complex heart health challenges. Edwards serves patients in over 100 countries through its comprehensive portfolio of products including the SAPIEN transcatheter heart valve system, INSPIRIS surgical valves, and advanced monitoring technologies. With a commitment to research and development, the company invests 17-18% of its revenue back into R&D efforts, maintaining its position at the forefront of structural heart innovation. Edwards Lifesciences has impacted over one million patients globally through its transformative medical technologies.