Biostatistician (Hybrid - Acton, MA)

Job Summary

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.

Position Overview:

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.

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. 

Education and Experience:

Minimum 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.

Preferred Skills and Competencies:

• 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.

Physical Requirements (if applicable):

Primarily sedentary role with standard office-based activities.
Occasional travel may be required for meetings, conferences, or team meetings.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $104,100.00 - $156,150.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.