Biostatistician (Hybrid - Acton, MA)
Insulet Corporation•US - Massachusetts, MA
•$104,100 - $156,150•Hybrid
About The Position
The Biostatistician will play a critical role in the design, analysis, and interpretation of clinical data to support product development, regulatory submissions, and publications. This position will contribute directly to the success of clinical programs, particularly those focused on diabetes-related technologies, and will collaborate cross-functionally to ensure statistical integrity and compliance with industry standards.
Requirements
- 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.
Nice To Haves
- Familiarity with real-world evidence (RWE) and health economics outcomes research (HEOR).
- Experience with adaptive trial designs or Bayesian methods.
- Experience with diabetes-related clinical studies.
- Knowledge of electronic data capture (EDC) systems and clinical databases.
- Excellent communication and collaboration skills.
- Strong analytical and problem-solving abilities.
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.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
