Biostatistician/SAS programmer

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: About This Role: We are seeking a detail-oriented and technically skilled Biostatistician/Data Analyst III to support the design, analysis, documentation, and reporting of clinical and healthcare-related activities. This position provides ongoing statistical and SAS programming support for Quality, production-related analyses, FDA and other regulatory topics, clinical studies, and scientific communications, with a focus on cardiology medical devices. The role requires strong statistical expertise and advanced proficiency in SAS programming to ensure the integrity, accuracy, and traceability of analyses used by cross-functional teams and in regulatory submissions. Essential Duties and Responsibilities: - Design and analyze clinical trials and observational studies in collaboration with cross-functional teams. - Develop and validate SAS programs for data manipulation, statistical analysis, and report generation. - Create and review statistical analysis plans (SAPs), study protocols, and data specifications. - Perform quality control checks on datasets, tables, listings, and figures (TLFs), including materials supporting Quality and regulatory activities. - Conduct statistical analyses using SAS and interpret results in the context of study objectives, quality questions, production needs, and FDA topics. - Provide statistical consultation and programming support to Clinical Research, Quality, Production, and other cross-functional teams. - Support FDA remediation, regulatory submissions, responses to agency questions, and associated documentation in compliance with applicable standards (e.g., CDISC, FDA, ICH). - Present statistical findings and explain analytical methods to internal and external stakeholders in a clear and concise manner. - Maintain and apply current statistical methodologies, SAS programming techniques, and best practices for data quality and reproducibility. Experience and Minimum Qualifications: - Master’s or PhD in Biostatistics, Statistics, or a related field. -At least 3 years of biostatistics or statistics work experience. - Strong proficiency in SAS programming (Base, Macro, SQL, and Statistical procedures). - Experience with clinical trial data and regulatory submissions (e.g., CDISC SDTM/ADaM standards). - Knowledge of statistical methods such as regression, survival analysis, and mixed models. - Familiarity with other statistical software (e.g., R, STATA) is a plus. - Excellent problem-solving, communication, and teamwork skills. - Ability to manage multiple projects and meet tight deadlines with high attention to detail. Location: Remote - US Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $99,000.00 - $129,000.00 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 iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY . For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121