Senior Principal Biostatistician

Edwards Lifesciences Belgium; Des Moines (IA); On-site; USD 151,000 - 215,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Principal Biostatistician to lead statistical methods across clinical development, regulatory submissions, and data quality assurance with robust scientific rigor.

You will mentor junior statisticians, design observational studies and trials, and collaborate with cross-functional teams to advance cardiovascular therapies and real-world evidence programs.

Qualifications

• Bachelor's Degree in Statistics, Biostatistics, or related field; 8 years analytical experience in clinical trials.
• Master's Degree or equivalent in Statistics, Biostatistics, or related field; 7 years analytical experience in clinical trials.
• Ph.D. or equivalent in Statistics, Biostatistics, or related field ; 4 years experience.

Responsibilities

• Lead end-to-end evidence strategies, designing observational studies, interventional trials, and real-world evidence programs.
• Build economic models to communicate clinical and economic value of Edwards products.
• Statistical lead on multiple clinical trials and coordination of analyses for reports and documents.
• Collaborate with cross-functional partners and external analysts on studies and partnerships.
• Represent Biostatistics on project teams and communicate timelines.
• Provide statistical expertise to stakeholders on ad hoc analyses and publications.
• Research and recommend novel statistical methodology and approaches.
• Contribute to standardization and globalization of Biostatistics processes and SOPs.
• Lead data analysis for data monitoring committees and mentor junior statisticians.

Skills

Biostatistics

Clinical Trials

SAS

R

Data Analysis

Leadership

Regulatory Submissions

Programming

Education

Bachelor's Degree in Statistics/Biostatistics

Master's Degree in Statistics/Biostatistics

Ph.D. in Statistics/Biostatistics

Tools

SAS

R

S-Plus

MS Office

Job description

USA - California – Irvine

Full time

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):

• 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

What else we look for (Preferred):

• 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 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 research setting
• 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

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.

For California, the base pay range for this position is $151,000 - $215,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.