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 and statistical analysis plans, conducting statistical analyses, presenting results, and developing SAS programs. This role requires a strong understanding of statistical concepts and techniques, as well as experience with SAS programming and industry standards.Responsibilities:

• Generate and verify randomization schedules.
• Develop and review statistical methods of the clinical study protocol.
• Provide and verify sample size calculations.
• Author statistical analysis plans.
• Generate analysis datasets, tables, figures, and listings using SAS.
• Perform quality control for statistical based SAS programs.
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
• Review statistical sections of clinical study reports.
• Work directly with sponsors, project managers, and external vendors.
• Lead 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.
• Excellent consultative, organizational, time management, communication, interpersonal, problem-solving, and presentation skills.

The role offers:

• Opportunity to work remotely.
• Chance to lead statistical activities for studies.
• Involvement in the development and maintenance of departmental procedures and standards.