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.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. 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 complex analysis datasets, specifications, and summary output (tables, listings, or graphs) for inclusion in clinical reports or presentations; Create complex programs that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (e.g SAS)
• Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review
• Perform complex analysis in response to data requests in collaboration with designated statistician
• Collaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checks

You will need (Required):

• Bachelor’s degree with 4 years of statistical programming experience OR
• Master’s degree with 2 years of statistical programming experience

• Advanced SAS programming skills (SAS/BASE, SAS/STAT, SAS/GRAPH)
• Good understanding of statistical techniques
• Proficiency in MS Office Suite

What else we look for (Preferred):

• Experience in clinical trials within the medical device, pharmaceutical, or biotech industry
• Good communication skills
• Full understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant in a pharmaceutical/medical device setting

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 Illinois, the base pay range for this position is $116,000 to $160,000 (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.