Principal Biostatistician

March 15

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🦀 Maryland – Remote

Although this job is listed in Maryland, this company may be open to hiring remote in other states.

💵 $129k - $182k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Edwards Lifesciences

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Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

Medical Devices • Heart Valves • Critical Care • Surgical Monitoring • Structural Heart Disease

10,000+ employees

Founded 1958

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Representing the TMTT 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. • Leading statistical efforts 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. • Collaborating 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. • Representing Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update. • Providing statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team. • Compiling technical documents for internal and external audits. • Contributing 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). • Collaborating on developing case report forms and clinical database to ensure quality data collection. • Leading the efforts of data analysis for data monitoring committee as needed.

🎯 Requirements

• Ph.D. in Biostatistics, Statistics, or related; plus, 2 full years of previous biostatistics, analytical experience in clinical trials • Master's Degree in Biostatistics, Statistics, or related; plus, 5 full years of previous biostatistics, analytical experience in clinical trials • Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses • 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 • Keeps abreast of new developments in statistics and regulatory guidance • Proven expertise in SAS • Experience using other software packages (e.g., R, S-Plus) • Extensive 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 serving as consultant to management; can effectively interact with suppliers, vendors and/or customers • 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