Biostatistician (Hybrid - Acton, MA)

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).
• 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.

Requirements

• 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.

Education

• Bachelor's in Biostatistics, Statistics, or a related field.

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.