Principal Biostatistician

Precision Medicine Group is seeking a highly skilled Principal Biostatistician to provide expert statistical support across all phases of clinical development. In this fully remote role, you will lead statistical activities, collaborate with global project teams, and ensure the integrity and accuracy of clinical trial data.

Key responsibilities

• Develop and review statistical methods for clinical study protocols, including complex study designs and sample size calculations.
• Author and review statistical analysis plans, including table, figure, and listing shells.
• Generate analysis datasets, tables, figures, and listings using SAS to support clinical trial reporting.
• Provide statistical expertise to Data Monitoring Committees and regulatory agencies.
• Lead statistical project components, manage timelines, and provide oversight for other biostatisticians.

Requirements

• Master’s degree in Statistics or Biostatistics with 10+ years of experience, or a PhD with 7+ years of experience.
• Advanced proficiency in SAS programming and a deep understanding of statistical principles in clinical trials.
• Comprehensive knowledge of industry standards, including ICH guidelines, CDISC data structures, and FDA regulations.
• Proven experience in consulting with clients on study design and late-phase submissions.
• Strong communication, problem-solving, and organizational skills to manage complex projects effectively.

What we offer

• Opportunity to work on diverse clinical projects, including oncology and rare diseases.
• A collaborative, global environment where you can act as a key consultant to internal and external stakeholders.
• Professional growth through involvement in departmental procedure development and mentoring opportunities.