Biostatistician/SAS Programmer
I
iRhythmDigital healthcare
Remote - USFull-TimeSenior
Salary99,000 - 129,000 USD per year
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Job Details
- Experience
- At least 3 years of biostatistics or statistics work experience.
Requirements
- 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.
- Excellent problem-solving, communication, and teamwork skills.
- Ability to manage multiple projects and meet tight deadlines with high attention to detail.
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).
- Conduct statistical analyses using SAS and interpret results in the context of study objectives and FDA topics.
- Provide statistical consultation and programming support to Clinical Research, Quality, and Production teams.
- Support FDA remediation, regulatory submissions, and responses to agency questions in compliance with CDISC, FDA, and ICH standards.
- Present statistical findings and analytical methods to internal and external stakeholders.
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