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Diabetes Youth Families

Biostatistician

Diabetes Youth Families

Biostatistician contributing to clinical data analysis and interpretation for medical device development. Collaborating across teams to ensure compliance and statistical integrity in diabetes technologies.

Posted 6/30/2026full-timeActon • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $104,100 - $156,150 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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.

Requirements

What you’ll need
  • 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

Benefits

Comp & perks
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)
  • And additional employee wellness programs

ATS Keywords

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Hard Skills & Tools
BiostatisticsStatistical AnalysisData ManagementRegulatory RequirementsClinical Study Reports (CSRs)Case Report Forms (CRFs)Data IntegrityStatistical MethodologiesData SummariesScientific Publications
Certifications
Bachelor's in BiostatisticsBachelor's in Statistics