Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Manager, Statistical Programming - Transcatheter Mitral & Tricuspid Therapies (TMTT) in Irvine, California

This is an exciting opportunity for an exceptional {insert title} professional with the 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, Statistical Programming will manage a team and oversee statistical programming activities within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit.

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.

Job Functions:

  • Lead a team of programmers in the development of program specifications and design documents in partnership with project statistician

  • Lead programming analysis datasets in multiple clinical trials for analysis for inclusion in clinical study reports, presentations, or select publications in collaboration with project statistician

  • Functions as the lead statistical programmer for specific projects

  • Develop a robust talent development plan in alignment with functional growth strategies of the department

  • Provide programming expertise on complex ad hoc data requests in collaboration with project statistician

  • Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties

  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review

  • Develop and revise statistical programming procedures or instructions

  • Assist in compiling technical documents for internal and external audits

Basic Qualifications:

  • Master’s degree in Statistics Mathematics, Computer Science or related field with 8 years of experience in statistical analysis

  • A minimum of 1 year leadership experience

  • Proven expertise in SAS and Windows operating systems

  • Proven expertise in graphs, figures, listing, and tables

  • Strong experience with macros, including utility macros

Preferred Qualifications:

  • Proven successful project management leadership skills

  • Experience with R, S-Plus, Python, etc preferred

  • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel

  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

  • Keeps abreast of new developments in statistics and regulatory guidance

  • Expert understanding of clinical trial and statistical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

  • Demonstrated track record in people management

  • Expert understanding and knowledge relevant to statistical programming

  • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

  • Excellent problem-solving, organizational, analytical and critical thinking skills

  • 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

  • Experience in facilitating change, including collaboration with management and executive stakeholders

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels

  • Ability to manage competing priorities in a fast paced environment

  • Must be able to work in a team environment, including participating and presenting at meetings, including with external representatives

  • 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

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 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.