Distinguished, Statistical Programming

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.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Develop, test, validate, document, maintain and execute programs in SAS and R and serve as lead programmer. He/she will take primary role in review and validation of SAS or R programs created by more junior-level programmers. In addition, will ensure that all appropriate documentation is appropriately filled out and approved.
   
• Provide programming expertise on multiple and complex clinical trials in programming, documentation, validation and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician
   
• Lead in programming analysis datasets in multiple and complex clinical trials
   
• Provide novel programming expertise on multiple and complex ad hoc data requests in collaboration with project statistician
   
• Lead a team of programmers in the development of novel, macros, tools, program specifications and design documents in partnership with project statistician
   
• Lead a team programmers in collaboration with clinical data management team to ensure that the databases is defined consistency across clinical trials and build databases in compliance with evolving regulatory standards
   
• Develop novel statistical programming, macros, tools and/or approaches
   
• Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
   
• Lead in the development or improvement of procedures and standards
   

• Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in Statistics, Mathematics, Computer Science or related field with 12 years experience of previous experience in statistical analysis Required or
• Master's Degree or equivalent in Statistics Mathematics, Computer Science or related field , 11 Years experience of previous experience Required or
• Ph.D. or equivalent in Statistics, Mathematics, Computer Science or related field , 8 years experience of previous experience Preferred

What else we look for (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 and knowledge relevant to statistical programming
   
• Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
   
• 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
   
• Strong leadership skills and ability to influence change
   
• Ability to provide training and coaching to lower level employees
   
• 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 interactions with higher,