Edwards Lifesciences · 3 hours ago
Senior Principal Biostatistician
Washington, United States
Full-time
Remote
Senior Level
$145K/yr - $205K/yr
4+ years exp
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Responsibilities
Provide impact as the statistical lead on multiple clinical trials
Lead the coordination of analyses for study report and other documents
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 on clinical trial design
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
Qualification
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Required
Master's Degree or equivalent in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials
Ph.D. or equivalent in Statistics, Biostatistics, or related field, Plus 4 years of previous analytical experience in clinical trials
Preferred
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
Keeps abreast of new developments in statistics and regulatory guidance
Experience in facilitating change, including collaboration with management and executive stakeholders
Ability to provide training and coaching to junior level employees
Strict attention to detail
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
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
Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus)
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10,001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (36)
2022 (69)
2021 (53)
2020 (32)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-10-18IPO· bmv:EW
Leadership Team
Michael A. Mussallem
Chairman & Chief Executive Officer
Carine Schorochoff
Senior Vice President
Recent News
GlobeNewswire News Room
2024-11-15
2024-11-07
Company data provided by crunchbase
