Director / Senior Director, Biostatistics - Oncology

Nuvalent, Inc. • Cambridge, MA

30d

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the Vice President, Biostatistics, the Senior Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including, protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at Nuvalent. The Senior Director, Statistics will also oversee CRO statistics deliverables for all Nuvalent studies.

Requirements

• Minimum of MS required (Ph.D. preferred) in Statistics, Biostatistics, or other related fields
• Sr Director: 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
• Director: MS with 10+ years (Ph.D. with 5+ years)
• 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
• 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

Benefits

• Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director