Senior Manager, Biostatistics, TMTT

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.

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. The Sr Manager, Biostatistics Level is lateral to Associate Director, Biostatistics ("Associate Director Biostatistics") level at Edwards.

This Senior Manager, Biostatistics, position is an excellent opportunity to utilize your expertise and grow your career with this innovative team!   

Key Responsibilities:

• 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

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

• Experience in clinical trial design, indication lead

• FDA/EMEA/PMDA submission experience

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 meetin