Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician FSP in Medical Affairs.

Key Responsibilities

• Provide statistical leadership and expertise for medical affairs study plans and protocols
• Lead statistical teams on clinical development projects, ensuring timely delivery of statistical outputs
• Review and contribute to study reports and regulatory submission dossiers, and manage biostatisticians and programmers when in a lead role

Required Qualifications

• Ph.D. or MS in Statistics, Biostatistics, or a related discipline
• Minimum of 5 years of experience in biostatistics/statistics within pharmaceutical or biotech clinical development
• Strong programming skills in SAS and/or R, including development and validation of tables, listings, and figures
• Experience producing statistical study reports and contributing to statistical sections of study protocols
• Proficiency with CDISC SDTM and ADaM standards and solid understanding of clinical trial design