Edwards Lifesciences Principal Biostatistician - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is an exciting opportunity for an exceptional biostatistician professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.
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.
Essential Job Functions / Key Responsibilities:
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
Statistical lead on Protocol, SAP and TLF development as well as CSRs
Collaborate with core stakeholders to provide statistical expertise in support of multiple new product development (NPD/IDE) 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
Basic Qualifications and Minimum Requirements:
Master's Degree in Statistics or Biostatistics, with 7 years of previous analytical experience in clinical trials, or
Ph.D. in Statistics or Biostatistics, with 4 years of previous analytical experience in clinical trials
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
Capable of independently leading pivotal trials
Proven expertise in SAS and R
Experience using PASS or EAST
Experience in trial simulations for sample size and power calculation
Familiar with survival, regression and categorical data analysis methods
Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
Medical Device experience
Extensive experience in PMA/PMDA/CE Mark submissions
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
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
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Ability to work in a team environment, including participating and presenting at meetings, including with external representatives
Ability to provide guidance to others on area of expertise
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.