Senior Principal Biostatistician

January 30

🏄 California – Remote

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

🔔 Pennsylvania – Remote

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

💵 $190k - $210k / year

⏰ Full Time

🟠 Senior

🧪 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

• Act as core team member/lead biostatistician of assigned clinical trial(s) in US and international/global trial • Accountable for clinical trials assigned to direct reports • Manage and oversee the work of small biostatistics team and may indirectly manage cross functional or matrix teams as appropriate. • Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams • Develop a robust talent development plan in alignment with functional growth strategies of the department • Develop and lead in the implementation of biostatistics strategies which may include negotiations with internal and external parties • Provide guidance on process improvement projects within biostatistics and cross-functional areas • Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization • Manage activities with the accountability for successful completion of all deliverables. • Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams • Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement) • Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities • Other incidental duties

🎯 Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required • Master's Degree or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required • Experience in clinical trial design, indication lead FDA/EMEA/PMDA submission experience