Principal Biostatistician

Job Description

Precision Medicine Group is seeking a Principal Biostatistician to provide statistical support for all phases of clinical development. This role involves writing and reviewing statistical sections of protocols and analysis plans, conducting statistical analyses, and developing SAS programs.

• Generating and verifying randomization schedules
• Developing and reviewing statistical methods for clinical study protocols
• Performing sample size calculations
• Providing input into case report form development
• Authoring statistical analysis plans
• Generating analysis datasets, tables, figures, and listings using SAS
• Performing quality control for statistical SAS programs
• Providing statistical support for regulatory agencies and ad-hoc requests
• Reviewing statistical sections of clinical study reports
• Leading all statistical activities for studies within timelines

Requirements for this position include:

• Master's or PhD degree in Statistics, Biostatistics, or related field
• 10+ years (Master's) or 7+ years (PhD) of experience
• Experience with SAS
• Knowledge of industry standards (ICH, CDISC, 21 CFR Part 11, FDA guidelines)
• Broad knowledge of advanced statistical concepts

Precision Medicine Group offers:

• Opportunity to work remotely
• Involvement in all statistical activities for studies