Principal Biostatistician

Job Description

Precision Medicine Group is seeking a Principal Biostatistician to provide statistical support for all phases of clinical development. The Principal Biostatistician will be responsible for writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets.Role involves:

• Generating and verifying randomization schedules
• Developing and reviewing statistical methods of the clinical study protocol
• Providing and verifying sample size calculations
• Authoring statistical analysis plans
• Generating analysis datasets, tables, figures, and listings using SAS
• Performing quality control for statistical based SAS programs
• Reviewing statistical sections of clinical study reports
• Leading all statistical activities for study within timelines

Requirements:

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Broad knowledge and superior understanding of advanced statistical concepts and techniques

Role offers:

• Remote work opportunity
• Opportunity to work with sponsors, project managers, and external vendors
• Opportunity to participate in the development and maintenance of departmental procedures and standards