Biostatistician (Hybrid - Acton, MA)

Location: Hybrid role requiring on-site work from an hirify.global office in Acton, Massachusetts, United States

Annual base salary: $104,100.00–$156,150.00, plus potential incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery technologies for diabetes and additional therapeutic areas.

What you will do

• Design and analyze clinical trials and observational studies with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D.
• Develop statistical analysis plans and perform analyses using SAS, MATLAB, and R.
• Provide statistical input for protocols, case report forms, and clinical study reports.
• Prepare statistical summaries and responses for regulatory submissions and agency queries.
• Support data integrity and ongoing data review during clinical studies.
• Contribute to scientific publications and presentations while monitoring applicable statistical methodologies and regulatory guidelines.

Requirements

• Bachelor’s degree in Biostatistics, Statistics, or a related field.
• At least 5 years of biostatistics experience in the medical device or pharmaceutical industry.
• Proficiency with SAS, MATLAB, and R for statistical programming and data analysis.
• Strong knowledge of clinical trial design, data management, and regulatory requirements, including FDA, EMA, ICH-GCP, and ISO standards.
• Ability to work in a hybrid arrangement with required on-site work from an hirify.global office.
• Strong communication, collaboration, analytical, and problem-solving skills.

Nice to have

• Experience with real-world evidence and health economics and outcomes research.
• Experience with adaptive trial designs or Bayesian methods.
• Experience in diabetes-related clinical studies.
• Knowledge of electronic data capture systems and clinical databases.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off.
• Employee wellness programs.
• Occasional travel may be required for meetings, conferences, or team meetings.