Director, Biostatistics

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as their Director/Senior Director of Biostatistics. Reporting to the VP of Biostatistics, you will lead statistical activities across all study and compound levels, from protocol development and study design to data analysis and regulatory submissions. You will oversee CRO statistical deliverables and collaborate extensively with internal and external teams. This role requires a strong background in biostatistics, oncology drug development, and regulatory submissions. The ideal candidate will possess excellent project management skills and a proven ability to manage competing priorities. Nuvalent offers a collaborative environment and the opportunity to contribute significantly to the advancement of cancer therapeutics.

Requirements

• Minimum of MS required (Ph.D. preferred) in Statistics, Biostatistics, or other related fields
• MS with 12+ years (Ph.D. with 8+ years) of overall experience, including at least 10+ years (at least 6+ years for Ph.D.) of experience in drug development in a CRO or pharma/biotech company
• Must have hands on experiences with SAS programming in clinical studies
• Experience with managing CROs and contractors
• Excitement about the vision and mission of Nuvalent and working on drug development
• Excellent project management skills and proven ability to manage competing priorities

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, proactively collaborate with internal and external team members in the 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, reviewer's 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 trials designs, particularly in oncology drug development

Preferred Qualifications

• Oncology experience is strongly preferred: familiar with oncology drug development, both early and late stage, including efficacy endpoints, RECIST criteria, common statistical issues and study designs in oncology
• Regulatory NDA/BLA submission experience is strongly preferred