Director, Biostatistics (Hybrid or Office-Based in Irvine, CA or Remote in US) - TMTTResponsible for leadership a team of biostatisticians and activities while ensuring the proper design, analysis, and presentation of clinical studies.Key Responsibilities:
Manage and oversee the work of a biostatistics team and have financial budget responsibilities.
Provide technical/statistical leadership and strategic input to multiple and/or complex clinical projects/programs in collaboration with cross-functional teams
Act as core team member/lead biostatistician of assigned clinical trial(s). Accountable for clinical trials assigned to direct reports
Develop a robust talent development plan in alignment with functional growth strategies of the department.
Develop and lead in the implementation of broad and more complex 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
Plan and manage complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, 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)
Provide resource analysis and planning for biostatistics functions
Other incidental duties
Education and Experience:Ph.D. or equivalent in in Statistics or Biostatistics, plus previous analytical experience in clinical trials with skill levels exceeding the requirements of the Manager Biostatistics Required orMaster's Degree or equivalent in Statistics or Biostatistics plus previous analytical experience in clinical trials with skill levels exceeding the requirements of the Manager Biostatistics RequiredAdditional 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 one or more teams 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 internal and external management and senior-level stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
Lead briefings and technical meetings for internal and external representatives
Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
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.
Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels
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.For California, the base pay range for this position is $169,000 to $239,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., 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.