This role can be remote, on-site or hybrid. An on-site or hybrid role would be based at the Irvine, CA Headquarters. Remote could be based anywhere within the US, this team adheres to West Coast hours, so we need someone to be open to working that time zone.

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 act as an independent contributor to provide programming support to ongoing studies and later play a pivotal leadership role within the Statistical Programming group. You will evaluate statistical programming requirements of computer environment and needs that relate to programming and reporting activities that foster use of emerging technologies in an innovative but compliant manner. You will oversee statistical programming activities for clinical studies and projects in your group, perform Senior Review of SAS outputs, ensuring high quality and timely deliverables.

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
• Other duties assigned by Leadership

What you’ll need (required)

Master's Degree or equivalent in Computer Science or Statistics or other related fields (may be considered to offset minimum experience requirement). Preferred
11 Year experience Solid SAS programming experience on clinical data in the pharmaceutical and/or medical device industry. Required
3 years’ experience Managing statistical programmers Required

What else we look for (Preferred)

• Knowledge of Windows operating systems required
• Good oral and written communication and management skills are essential
• Ability to understand
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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.

For California (CA), the base pay range for this position is $177,000 to $251,000 (highly experienced).

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