Senior Director, Biostatistics - Oncology

Role Summary

The Senior Director, Biostatistics is the project lead statistician responsible for statistical activities at study and compound levels, including protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations. The role also oversees CRO statistics deliverables for all studies.

Responsibilities

• Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis and reporting of clinical trial data
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• Oversee CRO statistical activities and manage contractor statisticians to ensure timely delivery of high-quality statistical outputs
• As the biostatistics representative, collaborate with internal and external team members in assigned projects, accountable for all statistics deliverables
• Contribute to the biostatistics vendor evaluation and selection
• Provide a thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewers' guides, and other relevant documents
• Contribute to the development of Biostatistics SOPs and standards
• Support study/program-level audit and inspection readiness activities as needed
• Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development

Competencies

• Adaptability/Flexibility
• Communication and Teamwork
• Effective Planning
• Perseverance
• Problem Solving
• Relationship Building
• Organizational Skills

Qualifications

• Minimum of MS required (Ph.D. preferred) in Statistics, Biostatistics, or related fields
• MS with 12+ years (Ph.D. with 8+ years) total experience, including at least 10+ years (at least 6+ years for Ph.D.) in drug development in a CRO or pharma/biotech company
• Oncology experience strongly preferred: familiarity with oncology drug development, endpoints, RECIST, and study designs in oncology
• Regulatory NDA/BLA submission experience strongly preferred
• Hands-on experience with SAS programming in clinical studies
• Experience managing CROs and contractors
• Commitment to Nuvalent's mission and drug development
• Excellent project management skills and ability to manage competing priorities