Associate Director, Global Biostatistics

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 4, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. USA - California - Irvine This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards's leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis. The Associate Director, Biostatistics (internally title Distinguished 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.

Key Responsibilities:

• Statistical lead on multiple and complex clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses while providing consultation on statistical methodology
• Collaborate with core stakeholders to provide statistical expertise in support of multiple and complex new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
• Develop and review the study proposal (or protocol) on statistical aspects
• Provide statistical input on endpoint definition, statistical methods, sample size calculation, acceptance criteria, and study success criteria
• Participation of writing and reviewing the study report
• Provide statistical input in data interpretation and conclusion
• Represent Biostatistics on multiple and complex project/study teams and c oordinate/communicate with management and other team members regarding project/study status and timeline update; including CDM and Stat Programming on database (EDC System and eCRF) review, testing, edit and quality checks, and statistical analysis programs
• Develop novel statistical methodology and/or approaches
• Lead in the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)
• Provide novel statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
• Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
• Compile technical documents for internal and external audits Basic Qualifications:
  • Master's Degree in Statistics, Biostatistics, or related field with 11 years of previous analytical experience in clinical trials or Ph.D. or equivalent in Statistics, Biostatistics, or related field and 8 years of experience
  • Proficiency in statistical programming language such as SAS and/or R required
  • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
  • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Medical Device research setting
  • Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses Preferred Qualifications:
    • 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 interactions with higher, equivalent and lower level internal and external representatives concerning decisions, scheduling requirements, and/or contractual clarifications E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 2 Days Ago Full time Req-7030 About Us 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 15,000 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.

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