This is an exciting opportunity for an exceptional biostatistician professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives.
The Manager, Biostatistics will be responsible for a team of biostatisticians and activities while ensuring the proper design, analysis, and presentation of clinical studies.
Essential Job Functions / Key Responsibilities:
Act as core team member/lead biostatistician of assigned clinical trial(s). Accountable for clinical trials assigned to direct reports.
Manage and oversee the work of a 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
Provide statistical insight/strategies to study design for complex clinical studies
Develop a robust talent development plan in alignment with functional growth strategies of the department
Develop and lead 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 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
Basic Qualifications and Minimum Requirements:
Master's Degree in Statistics or Biostatistics, with 7 years of previous analytical experience in clinical trials, or
Ph.D. in Statistics or Biostatistics, with 4 years of previous analytical experience in clinical trials
Proficiency in a statistical programming language such as SAS and R
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite
Proven track of successful experience in NDA/IDE/PMA/PMDA/CE mark submissions
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
Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Capable of independently leading pivotal trials
Experience using PASS or EAST
Experience in trial simulations for sample size and power calculation
Familiar with survival, regression and categorical data analysis methods
Medical Device experience
Adaptive design experience
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
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
Additional Talents and General Expectations:
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 proactive 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
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don't miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.