Statistics Leader – Associate Director of Statistics

Provide statistical leadership for oncology studies/indications, partnering with project and study teams to align strategy and execution
Lead statistical strategy for study design, analysis, reporting, and interpretation, applying fit-for-purpose methods (e.g., simulation, interim strategies, Bayesian) to quantify uncertainty and inform decisions
Author/review statistical sections of protocols, SAPs, clinical/regulatory documents, and presentations; communicate complex results clearly to non-statistical stakeholders
Ensure high-quality, on-time deliverables and effective stakeholder management in a matrix environment
Drive innovation in statistical methodology and data strategy, including appropriate use of external/real-world data to strengthen oncology evidence generation
Build deep indication knowledge (e.g., regulatory expectations, competitor landscape) and influence asset strategy and regulatory submissions with rigorous statistical insight
Represent Oncology Biostatistics externally as appropriate and may serve as project statistician for an oncology asset.

• PhD in Statistics or a related quantitative field with at least 5 years post-degree experience OR MS/MSc in Statistics (or related quantitative field) with 8+ years of clinical development experience.
• Experience supporting clinical development in pharmaceutical, biotech, or CRO settings.
• Experience delivering fit-for-purpose statistical solutions and supporting study design and readouts
• Experience with R and/or Python
• Working knowledge of SAS (preferred)
• Hands-on expertise in statistical modeling and innovative methods (e.g., Bayesian approaches) (preferred)
• Thorough knowledge of the drug development process including late-phase development, registration activities, and oncology regulatory expectations (preferred)
• Familiarity with causal inference and/or AI/ML methods, and interest in applying these approaches (when appropriate) to clinical and/or real-world data (preferred)
• Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence (preferred)
• Strong communication and stakeholder-management skills, with demonstrated ability to influence across functions in a matrix environment (preferred)
• Highly organized, self-directed, and able to manage multiple priorities across projects (preferred).

Expertise in statistical leadership for oncology studies, with a strong focus on study design, analysis, and reporting. Proficient in applying innovative statistical methodologies and managing stakeholder communications effectively in a matrix environment.

• PhD In Statistics Or Related Quantitative Field
• Experience In Clinical Development
• Statistical Modeling Expertise
• R And/or Python Proficiency
• Strong Communication And Stakeholder Management Skills

• Statistical Strategy Development
• Bayesian Methods
• Statistical Analysis Plan (SAP) Authoring
• Statistical Modeling
• Causal Inference
• AI/ML Methods
• Fit-For-Purpose Statistical Solutions
• Oncology Regulatory Knowledge
• Clinical Study Design
• Data Strategy Innovation

• Effective Communication
• Influence Across Functions
• Highly Organized
• Self-Directed
• Stakeholder Management

• Oncology
• Clinical Development
• Pharmaceutical
• Biotech
• CRO
• Regulatory Submissions
• Real-World Data
• Late-Phase Development
• Registration Activities
• Matrix Environment

• R
• Python
• SAS