Principal Biostatistician

Edwards Lifesciences Belgium; Indianapolis (IN); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Biostatistician to apply advanced biostatistical methods across clinical trials and regulatory submissions. You will implement methodologies, generate results, and guide data-driven decision-making in a highly collaborative environment.

Responsibilities include leading analyses, coordinating study reports, and mentoring junior statisticians while ensuring compliance with GCP, ICH, FDA, and ISO standards.

Qualifications

• 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 in clinical trials required.

Responsibilities

• Statistical lead on multiple clinical trials, coordinate analyses for study reports and provide programming and validation support.
• Collaborate with core stakeholders to provide statistical expertise for multiple NPD and/or regulatory submissions (e.g., PMA, CE Mark, PMDA).
• Represent Biostatistics on project teams and coordinate with management on status and timelines.
• Research and recommend novel statistical methodologies and provide guidance on ad hoc analyses and publications.
• Prepare technical documents for audits and regulatory submissions.
• Contribute to Biostatistics SOPs and Work Instruction Manuals development.
• Lead data analysis efforts for data monitoring committees as needed.
• Mentor junior statisticians and support budget/timeline planning.

Skills

R proficiency

Statistical modeling

Leadership

Communication

Regulatory knowledge

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

R

S-PLUS

CDISC SDTM

CDISC ADaM

MS Office

Job description

USA - California - Irvine

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 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.

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 of 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

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.

The base pay range for this position is $132,000 to $186,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.