Prin Statistician

• Statistical Analysis
• Clinical Research
• SAS Programming

Key Responsibilities:

• Design and lead statistical analysis for clinical studies and medical device R&D.
• Develop study protocols, Statistical Analysis Plans (SAPs), and clinical study reports.
• Perform sample size/power calculations, statistical modeling, and data analysis using SAS and/or R.
• Support clinical trial design, regulatory submissions (FDA/global), and interpretation of study results.
• Validate statistical programs and prepare reports, tables, listings, and figures.
• Collaborate with clinicians, programmers, and cross-functional teams.
• Mentor junior statisticians and provide statistical leadership.

Required Skills:

• MS/PhD in Biostatistics, Statistics, or related field (BS with additional experience accepted).
• 5+ years of biostatistics/data analysis experience.
• Clinical trial design and analysis.
• Strong SAS programming (R preferred).
• Experience with SAPs, sample size calculations, survival analysis, regression, Bayesian methods, longitudinal/mixed models, adaptive designs, interim analysis, and missing data methods.
• Knowledge of GCP, FDA/global regulatory submissions, and medical device/pharma clinical research.
• Strong communication and technical documentation skills.