Edwards Lifesciences
Senior Manager, Biostatistics
Edwards Lifesciences, Concord, New Hampshire, United States, 03306
Edwards Lifesciences Senior Manager, Biostatistics - Concord, New Hampshire
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.Responsibilities:Act as core team member/lead biostatistician of assigned clinical trial(s) in the US and international/global trialAccountable for clinical trials assigned to direct reportsManage and oversee the work of a small biostatistics team and may indirectly manage cross-functional or matrix teams as appropriateProvide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teamsDevelop a robust talent development plan in alignment with functional growth strategies of the departmentDevelop and lead in the implementation of biostatistics strategies which may include negotiations with internal and external partiesProvide guidance on process improvement projects within biostatistics and cross-functional areasCreate, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimizationManage activities with the accountability for successful completion of all deliverables. Identify risks, develop mitigation strategies, alternative solutions, resolve issues, action item follow-up, etc. in collaboration with cross-functional and/or matrix teamsProvide 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 activitiesOther incidental dutiesMinimum Requirements:Ph.D. or equivalent in Statistics, Biostatistics, or a related field with previous analytical experience in clinical trials exceeding the requirements of the Associate ManagerExperience in clinical trial design, indication leadThe location for this position can be remote within the United StatesPreferred Qualifications:Proficiency in statistical programming languages such as SAS and/or R requiredProven successful project management leadership skillsExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive achievement of objectivesPromote a culture of collaboration and teamworkExpert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problemsExpert understanding of related aspects of biostatistics processes and/or systemsDemonstrated ability to manage an assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relationsStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to work and excel within a fast-paced, dynamic, and constantly changing work environmentThe Senior Manager, Biostatistics level is lateral to the Associate Director, Biostatistics level at Edwards.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards Lifesciences is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, 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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Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.Responsibilities:Act as core team member/lead biostatistician of assigned clinical trial(s) in the US and international/global trialAccountable for clinical trials assigned to direct reportsManage and oversee the work of a small biostatistics team and may indirectly manage cross-functional or matrix teams as appropriateProvide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teamsDevelop a robust talent development plan in alignment with functional growth strategies of the departmentDevelop and lead in the implementation of biostatistics strategies which may include negotiations with internal and external partiesProvide guidance on process improvement projects within biostatistics and cross-functional areasCreate, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimizationManage activities with the accountability for successful completion of all deliverables. Identify risks, develop mitigation strategies, alternative solutions, resolve issues, action item follow-up, etc. in collaboration with cross-functional and/or matrix teamsProvide 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 activitiesOther incidental dutiesMinimum Requirements:Ph.D. or equivalent in Statistics, Biostatistics, or a related field with previous analytical experience in clinical trials exceeding the requirements of the Associate ManagerExperience in clinical trial design, indication leadThe location for this position can be remote within the United StatesPreferred Qualifications:Proficiency in statistical programming languages such as SAS and/or R requiredProven successful project management leadership skillsExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive achievement of objectivesPromote a culture of collaboration and teamworkExpert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problemsExpert understanding of related aspects of biostatistics processes and/or systemsDemonstrated ability to manage an assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relationsStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to work and excel within a fast-paced, dynamic, and constantly changing work environmentThe Senior Manager, Biostatistics level is lateral to the Associate Director, Biostatistics level at Edwards.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards Lifesciences is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, 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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