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

Competencies Include:

• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds productive working relationships across a diverse spectrum of people.
• Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

 Qualifications:

• Minimum of an MS required (Ph.D. preferred) in Statistics, Biostatistics, or other related fields.
• MS with 10+ years of or Ph.D. with 6+ years of experience in drug development in a CRO or pharma/biotech company
• 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 experience 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.