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:

• Develop, test, validate, document, maintain and execute programs in SAS and serve as lead programmer. He/she will take primary role in review and validation of SAS 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 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 clinical trials
• Provide programming expertise on complex ad hoc data requests in collaboration with project statistician
• Lead a team of programmers in the development of program specifications and design documents in partnership with project statistician.
• Collaborate with management to develop or improve procedures and standards
• Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trials
• Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review

What you'll need (Required):

• Bachelor's Degree in Statistics Mathematics, or Computer Science with 8 years of previous experience in Statistical Analysis
• Masters Degree or equivalent in Statistics Mathematics or Computer Science with 7 years of previous experience required
• PHD or equivalent in Statistics Mathematics or Computer Science with 4 years of previous experience Required

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 participating and presenting at meetings, including with external representatives
• Ability to provide guidance to others on area of expertise

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 $148,000 to $210,000 (highly experienced).   

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).   Applications will be accepted while this position is posted on our Careers website.