Edwards Lifesciences Principal Biostatistician- Forecasted Opportunity in Irvine, California
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.
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 • 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)x000D Lead the efforts of data analysis for data monitoring committee as neededx000D Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
Education and Experience: Bachelor's Degree in in Statistics, Biostatistics, or related field, 8 years years experience of previous analytical experience in clinical trials Required or Master's Degree or equivalent in in Statistics, Biostatistics, or related field, 7 years years experience of previous analytical experience in clinical trials Required or Ph.D. or equivalent in in Statistics, Biostatistics, or related field , 4 years years experience of experience Required
Additional Skills: • 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 • 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 • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.