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, conducting statistical analyses, and developing SAS programs.

• Generating and verifying randomization schedules
• Developing and reviewing statistical methods of the clinical study protocol
• Performing or assisting with advanced calculations including adaptive design
• Authoring statistical analysis plans
• Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Providing statistical analysis and reports to Data Monitoring Committees (DMCs)
• Reviewing statistical sections of clinical study reports

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

The role offers:

• The opportunity to work remotely in Hungary
• The chance to lead all statistical activities for studies
• The ability to participate in the development and maintenance of departmental procedures and standards