Director / Sr. Director, Biostatistics (Oncology)

at  Nuvalent Inc

THE COMPANY:

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 Director / Sr. Director, 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. This person will also oversee CRO statistics deliverables for all Nuvalent 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, 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