Vacancy expired!
Senior Manager, Biostatistics, (Remote, USA) Transcatheter Mitral & Tricuspid Therapies
The Sr Manager, Biostatistics Level is lateral to Associate Director, Biostatistics ("Associate Director Biostatistics") level at Edwards
Edwards' transcatheter mitral and tricuspid therapies (TMTT), and specialized cardiologists, are making a meaningful mark on the lives of patients with mitral and tricuspid regurgitation. Mitral and tricuspid regurgitation affect more than 10% of people aged 65 and over in the US, creating a poor quality of life and high mortality rates. This Senior Manager, Biostatistics, open position is an excellent opportunity to utilize your expertise and grow your career with this innovative team!As Senior Manager, Biostatistics, you are responsible for leading a team of biostatisticians and overseeing activities while ensuring the proper design, analysis, and presentation of clinical studies.Key Responsibilities:
Act as core team member/lead biostatistician of assigned clinical trial(s) in US and Japan
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
Education and Experience:
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
Additional Skills :
Proficiency in statistical programming language such as SAS and/or R required
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
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
Strict attention to detail
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
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
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
Dedicated to quality client service and pro-active and responsive to client needs.
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
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
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.The base pay range for this position is $141,000 to $200,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as 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.
