[Hiring] Biostatistician/SAS Programmer @iRhythm Technologies, Inc.

Role Description

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.

• 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.

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

Estimated Pay Range

$99,000.00 - $129,000.00

Company Description

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.