Senior Manager, Biostatistics - Edwards Lifesciences
Indianapolis, IN
About the Job
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.
As Senior Manager, Biostatistics, TMTT , you will use your expertise as biostatistical lead in clinical study design projects for pivotal trials, while overseeing activities to ensure proper design, analysis, and presentation of clinical studies.
How you will make an impact:
+ 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
What you'll need (Required):
+ Ph.D. or equivalent in in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required or
+ Master's Degree or equivalent in 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
+ The location for this position can be remote within the United States
What else we look for (Preferred) :
+ Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
+ Expert understanding of related aspects of biostatistics processes and/or systems
+ Demonstrated ability to manage 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 relations
+ Dedicated to quality client service and pro-active and responsive to client needs.
+ Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
+ Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
+ Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
+ Participate and present at meetings with internal and external representatives
+ Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
+ Develop relationships and leverage them to influence change
+ Support and solicit input from team members at all levels within the organization
+ Proficiency in statistical programming language such as SAS and/or R required
+ Strict attention to detail
+ Proven successful project management leadership skills
+ Proven expertise in both Microsoft Office Suite
+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
+ Promote a culture of collaboration and teamwork
+ Resolve operational and scheduling issues
+ 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
The Sr Manager, Biostatistics Level is lateral to Associate Director, Biostatistics ("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.
For California, the base pay range for this position is $190,000 to $210,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards 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.
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.
As Senior Manager, Biostatistics, TMTT , you will use your expertise as biostatistical lead in clinical study design projects for pivotal trials, while overseeing activities to ensure proper design, analysis, and presentation of clinical studies.
How you will make an impact:
+ 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
What you'll need (Required):
+ Ph.D. or equivalent in in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required or
+ Master's Degree or equivalent in 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
+ The location for this position can be remote within the United States
What else we look for (Preferred) :
+ Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
+ Expert understanding of related aspects of biostatistics processes and/or systems
+ Demonstrated ability to manage 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 relations
+ Dedicated to quality client service and pro-active and responsive to client needs.
+ Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
+ Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
+ Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
+ Participate and present at meetings with internal and external representatives
+ Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
+ Develop relationships and leverage them to influence change
+ Support and solicit input from team members at all levels within the organization
+ Proficiency in statistical programming language such as SAS and/or R required
+ Strict attention to detail
+ Proven successful project management leadership skills
+ Proven expertise in both Microsoft Office Suite
+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
+ Promote a culture of collaboration and teamwork
+ Resolve operational and scheduling issues
+ 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
The Sr Manager, Biostatistics Level is lateral to Associate Director, Biostatistics ("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.
For California, the base pay range for this position is $190,000 to $210,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards 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.
Source : Edwards Lifesciences
