Director Statistical Programming

Edwards Lifesciences•Irvine, CA

1d•$182,000 - $257,000

About The Position

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you’ll make an impact: As the Director of Statistical Programming, you will lead teams of programmers to develop, test, validate, document, maintain and execute programs in SAS to support statistical deliverables within agreed timelines. He/she will mentor and develop programmers and allocate statistical programming resources under the provided project priorities and timeline. Facilitate talent management activities to include hiring, training, staff development and succession planning. Mentor and develop team of programmers by providing regular coaching and guidance. Manage people resource allocation of statistical programming. Prepare, document, and review programming codes and output for own project and/or as needed to ensure the quality of programming output. Review ADS Specs and output for own project and/or other projects Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review Participate in the development of procedures and standards and adherence to existing procedures Prepare analysis datasets Develop program specification and design documents

Requirements

Master's Degree in Computer Science or Statistics or other related fields
11 Year experience
Solid SAS programming experience on clinical data in the pharmaceutical and/or medical device industry.
3 years’ experience Managing statistical programmers

Nice To Haves

Proven successful project management leadership skills
Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
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 stakeholder
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

Responsibilities

Lead teams of programmers to develop, test, validate, document, maintain and execute programs in SAS to support statistical deliverables within agreed timelines.
Mentor and develop programmers and allocate statistical programming resources under the provided project priorities and timeline.
Facilitate talent management activities to include hiring, training, staff development and succession planning.
Mentor and develop team of programmers by providing regular coaching and guidance.
Manage people resource allocation of statistical programming.
Prepare, document, and review programming codes and output for own project and/or as needed to ensure the quality of programming output.
Review ADS Specs and output for own project and/or other projects
Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
Participate in the development of procedures and standards and adherence to existing procedures
Prepare analysis datasets
Develop program specification and design documents