Edwards Lifesciences Director, Biostatistics - Transcatheter Heart Valve in Irvine, California
Edwards has an opportunity for a Biostatistics Director in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease. This individual will be responsible for oversight, guidance and leadership of the Biostatistics team. The Director must have the skills necessary to interact with Department staff, Corporate management, clients, consultants and regulatory agencies, and is responsible for budgeting the Biostatistics function.
Essential Job Functions/Key Responsibilities:
Line management responsibility in accordance with Edwards’ policies and procedures, and all applicable regulations and guidance for the Biostatistics team.
Responsible for appraising performance and guiding professional development; rewarding and performance managing employees; addressing employee relations issues and resolving problems; approving actions for human resources matters.
Responsible for planning, assigning and directing work; creating SOPs and work instructions for statistical functions; establishing and organizing the standardization of statistical analysis.
Promotes teamwork within Biostatistics and across multiple functional areas to ensure a successful collaboration within Biometrics and with cross functional areas.
Responsible for the statistical input provided by the group to major documents including documents for submissions to government agency communications, statistical analysis plans, clinical study reports and summaries of clinical safety and effectiveness.
Responsible for the planning, creation, and distribution of analysis data sets provided by the statisticians and statistical programmers.
Serves as an advisor for technical issues associated with the planning, design, interpretation, and analysis of clinical study data.
Oversees the assessment, development and validation of all statistical outcomes.
Provides review and guidance regarding statistical aspects of Company interactions with FDA, Notified Bodies, and other regulatory agencies.
Works closely with business units to ensure a coordinated approach to statistical support and statistical activities.
Maintains knowledge of current best practices and regulatory guidance in the area of statistics as they apply to registration filings as well as day to day statistical activities.
Coordinates activities with European clinical affairs for the needs of statistical support in Europe.
Participates in departmental/corporate committees and teams.
Makes presentations, trains and mentors as requested by business units or other users.
Leads and manages the relationships with external industry statistical experts for consultation needs.
Basic Qualifications and Minimum Requirements:
Ph.D. in Biostatistics or Statistics with 10 or more years of experience in statistical function area within the medical device, pharmaceutical, or CRO industry.
Must have 3 or more years of people management experience.
Proficiency in SAS and R.
Strong IT and computer skills.
Strong analytical skills particularly in biostatistics.
Familiarity with regulatory processes and data requirements for successful marketing submissions.
Ability to engage, develop and manage a team of highly skilled professionals.
Strong communication and influencing skills.
Strong organizational and prioritization skills.
Ability to handle multiple projects and work in a team environment.
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.