Principal Biostatistician

Edwards Lifesciences•Irvine, CA

3d•$129,000 - $182,000

About The Position

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 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

Requirements

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

Nice To Haves

Training or publications in Bayesian methodology
Expertise in MS Office (Word, PowerPoint, Access, Excel)
Strong written/verbal communication and relationship management skills
Up-to-date on statistical and regulatory developments
Deep knowledge of clinical trial design, statistical modeling, and data analysis
Proficient in SAS; experience with R, S-Plus
Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices
Excellent problem-solving, analytical, and critical thinking skills
Proven leadership and ability to influence change
Skilled in training/coaching and facilitating organizational change
Detail-oriented; able to manage competing priorities in fast-paced environments
Professional interaction across all levels; collaborative team player and consultant to management

Responsibilities

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

Benefits

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume