at Edwards Lifesciences in Remote, United States
An exciting opportunity with the Advanced Technologies team currently involved in new cutting edge products and processes. In this innovative team you will be responsible for a team of biostatisticians and activities while ensuring the proper design, analysis and presentation of clinical studies. This position leverages applied research, design and development experience in new medical device and product development.
Essential Job Functions/Key Responsibilities:
+ Direct biostatistics activities with overall responsibility of managing vendors, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through several managers and/or SMEs.
+ Develop a robust talent development and succession planning in alignment with functional growth strategies across the global biostatistics organization. Build an effective team across the organization
+ Provide strategic clinical and statistical leadership to entire portfolio of business unit in collaboration with cross-functional areas (e.g., Clinical Affairs, Medical Affairs)
+ Mitigate/eliminate risk, direct and communicate highly complex biostatistics strategies which includes negotiations with internal and external parties
+ Analyze, formulate and present statistical recommendations to advise and guide executive level leadership; develop and deliver executive level communication
+ 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 direct strategic activities including prioritizing and allocating resources for projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, 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)
+ PhD in Statistics, Biostatistics or related field with 11 years of previous analytical experience in clinical trials OR
+ Master’s degree in Statistics, Biostatistics or related field with 14 years of previous analytical experience in clinical trials
+ Proficiency in statistical programming language such as SAS and/or R
+ Familiarity with clinical data management principles, CRF design and EDC systems
+ Proven successful project management leadership skills
+ 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 direct 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
+ Local or ability to relocate to Orange County and work onsite at Edward’s global headquarters. Full relocation package provided.
For Colorado Residents Only:
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 $214,000 to $250,000.
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards 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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
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.