Principal Statistician

Principal Statistician Overview

• The Principal Statistician role involves statistical analysis and clinical research for medical device development.
• Collaborate with clinical, regulatory, and data management teams to ensure project success.
• Work remotely with a team of approximately ten professionals, led by a skilled hiring manager.
• Design and execute biostatistical components of research and development projects.
• Provide statistical expertise for clinical trials and regulatory submissions.
• Develop and apply statistical theories, methods, and software for data analysis.
• Summarize and interpret data into formats suitable for statistical inference.
• Mentor and train statisticians in their roles and responsibilities.

Principal Statistician Key Responsibilities & Duties

• Design and execute statistical components for clinical research projects.
• Prepare statistical protocols meeting health authority guidelines and clinical trial standards.
• Conduct statistical analyses using software such as SAS and R.
• Summarize data into tabular and graphical formats for reports and publications.
• Collaborate with clinicians and programmers to ensure accurate data analysis.
• Support regulatory review and approval processes for experimental therapies.
• Develop policies and procedures for statistical practices within the department.
• Respond to regulatory inquiries and participate in FDA meetings.

Principal Statistician Job Requirements

• Master’s degree in Biostatistics, Statistics, or equivalent required; PhD preferred.
• Minimum of 5 years of statistical experience; 7 years preferred.
• Proficiency in statistical programming packages such as SAS and R.
• Experience with clinical study data analysis and trial design.
• Knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines.
• Strong applied statistical skills, including regression modeling and survival analysis.
• Ability to communicate complex statistical results to diverse audiences.
• Experience in FDA regulatory submissions and panel presentations.