生物统计学家/SAS程序员
Biostatistician/SAS programmer
职业决定性。改变人生。
在iRhythm,你将有机会提升技能和职业生涯,同时影响全球人们的生活。iRhythm正在塑造一个未来,让世界各地的每个人都能获得最佳的心脏健康解决方案。每天,我们协作、创造,并不断重新想象可能性。我们志向远大,行动迅速,致力于以患者为先,改善生命。我们需要像你这样的建设者。充满好奇心和创新精神的问题解决者,寻找机会有意义地塑造心脏健康、公司以及你自己的未来。
职位简介:
我们正在寻找一位注重细节且技术能力强的生物统计学家/数据分析师III,以支持临床和医疗相关活动的设计、分析、文档和报告。该职位为质量、生产相关分析、FDA及其他监管议题、临床研究和科学沟通提供持续的统计和SAS编程支持,重点在于心脏医疗设备。该职位需要强大的统计专业知识和高级的SAS编程能力,以确保跨职能团队和监管提交中使用的分析的完整性、准确性和可追溯性。
主要职责和任务:
- 与跨职能团队合作,设计和分析临床试验和观察性研究。
- - 开发和验证用于数据处理、统计分析和报告生成的SAS程序。
- - 创建和审查统计分析计划(SAPs)、研究方案和数据规范。
- - 对数据集、表格、列表和图形(TLFs)进行质量控制检查,包括支持质量和监管活动的材料。
- - 使用SAS进行统计分析,并在研究目标、质量问题、生产需求和FDA议题的背景下解释结果。
- - 为临床研究、质量、生产和其他跨职能团队提供统计咨询和编程支持。
- - 支持FDA整改、监管提交、机构问题答复及相关的文档,符合适用标准(如CDISC、FDA、ICH)。
- - 清晰简洁地向内部和外部利益相关者展示统计发现并解释分析方法。
- - 维护并应用当前的统计方法、SAS编程技术和最佳实践。
查看英文原文
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 - USActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$99,000.00 - $129,000.00As 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
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 . Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
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Originally posted on Himalayas