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Biostatistician
Job in
Acton, Middlesex County, Massachusetts, 01720, USA
Listed on 2026-08-02
Listing for:
Jobtailor
Full Time
position Listed on 2026-08-02
Job specializations:
-
Research/Development
Clinical Research, Data Scientist, Medical Science -
Healthcare
Clinical Research, Data Scientist, Medical Science
Job Description & How to Apply Below
Responsibilities
- Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D
- Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R
- Provide statistical input for study protocols, case report forms (CRFs), and clinical study reports (CSRs)
- Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO)
- Provide data summaries to support data integrity and data review during ongoing studies
- Support regulatory submissions with statistical summaries and responses to agency queries
- Contribute to scientific publications and presentations of clinical data
- Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research.
- Performs other duties as required.
- Bachelor's in Biostatistics, Statistics, or a related field
- Minimum of 5 years of experience in biostatistics within the medical device or pharmaceutical industry
- Proficiency in statistical tools, such as SAS, MATLAB, and R for programming and data analysis
- Strong understanding of clinical trial design, data management, and regulatory requirements
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