Insulet Corporation is looking for a Biostatistician to support product development, regulatory submissions, and publications, particularly for diabetes-related technologies, ensuring statistical integrity and compliance with industry standards.
Requirements
- 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.
- 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.
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.
Other
- Minimum of 3 years of experience in biostatistics within the medical device industry.
- Master’s or Ph.D. in Biostatistics, Statistics, or a related field.
- Excellent communication and collaboration skills.
- Strong analytical and problem-solving abilities.
- Eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).
