Principal Biostatistician

Edwards Lifesciences; Irvine (CA); On-site; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analyses across clinical development, from trial designs to regulatory submissions, applying rigorous methods to endpoints and data quality. You will collaborate with investigators and regulatory authorities to drive the evidence needed to optimize patient outcomes.

The role requires a PhD in Statistics/Biostatistics with 2+ years of experience, strong SAS expertise, survival analysis familiarity, and excellent

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience
• Survival analysis experience
• Proven expertise in SAS
• Experience using other software packages (e.g., R, S-Plus)
• Statistical Analysis Plans (SAP)
• 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
• Extensive understanding of regulatory guidelines (GCP, ICH, FDA, ISO) relevant to Pharmaceutical/Medical Device research

Responsibilities

• Statistical lead on one or more clinical trials, coordinating analyses for study reports
• Provide programming and validation support for analyses
• Collaborate with stakeholders on statistical support for new product development and regulatory submissions
• Represent Biostatistics on project teams and communicate status and timeline
• Provide statistical expertise on ad hoc data analysis requests and publications
• Compile technical documents for audits
• Contribute to standardizing Biostatistics processes and SOPs
• Collaborate on developing case report forms and clinical databases
• Lead data analysis efforts for data monitoring committees as needed

Skills

Survival analysis

SAS

R/S-Plus

SAP

MS Office

Communication

Education

PhD in Statistics/Biostatistics

Tools

SAS

R

S-Plus

Job description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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 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:

• Statistical lead on one or more 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 new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed

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

• Provide statistical expertise 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)

• Collaborate on developing case report forms and clinical database to ensure quality data collection

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

What you’ll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience

What else we look for (Preferred):

• Survival analysis experience

• Proven expertise in SAS

• Experience using other software packages (e.g., R, S-Plus)

• Statistical Analysis Plans (SAP).

• 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

• Keeps abreast of new developments in statistics and regulatory guidance
  Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses

• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

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 $132,000 - $186,000 (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.