Senior Quality/Regulatory Biostatistician

Career-defining. Life-changing. 

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

We are seeking a skilled and detail-oriented Biostatistician to support ongoing statistical work in Quality, with a strong emphasis on regulatory submissions, quality improvement and monitoring, and clinical trial planning. The ideal candidate will have experience applying statistical methodologies in a regulated environment, particularly in support of FDA and international regulatory requirements. This role is critical to ensuring the statistical integrity of quality systems data, driving continuous improvement initiatives, and contributing to the design and analysis of clinical studies that support product safety and effectiveness.

What You Will Be Doing

• Provide statistical expertise for regulatory submissions, including PMAs, 510(k)s, IDEs, and responses to regulatory agency queries.
• Support Quality Assurance and Quality Improvement teams by analyzing manufacturing, post-market surveillance, and complaint data to identify trends, monitor performance, and drive corrective and preventive actions (CAPA).
• Design and implement statistical methods for quality monitoring, control charts, process capability analysis, and other tools to support continuous improvement.
• Collaborate with cross-functional teams to design statistically sound protocols for clinical trials and real-world evidence studies.
• Develop and review statistical analysis plans, protocols, and reports for regulatory and clinical deliverables.
• Ensure statistical methods and documentation meet FDA, EMA, and other global regulatory requirements.
• Perform statistical analyses using SAS, R, or equivalent software, and interpret results in the context of regulatory and quality expectations.
• Contribute to internal audits and inspections by providing statistical justifications and documentation.
• Stay current with evolving regulatory guidelines and statistical best practices in the medical device and healthcare industries.

What We Need To See

• Master’s or PhD in Biostatistics, Statistics, or a related field.
• Minimum of 5 years of experience in a regulated healthcare environment, preferably in medical devices or diagnostics.
• Demonstrated experience supporting regulatory submissions with statistical content.
• Proficiency in statistical software such as SAS, R, or STATA.
• Strong understanding of FDA, ICH, and ISO statistical requirements.
• Experience with quality systems data, post-market surveillance analytics, and quality improvement methodologies (e.g., Six Sigma, Lean) is highly desirable.
• Excellent communication skills, with the ability to explain complex statistical concepts to non-statistical stakeholders.

Ways To Stand Out

• Proficiency in statistical software such as SAS, R, or STATA.
• Strong understanding of FDA, ICH, and ISO statistical requirements.

 

Location:

Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$123,000.00 - $160,000.00

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhy