Description
GSK Oncology is seeking a Statistics Director to provide end-to-end statistical leadership across oncology evidence generation.
You will lead statistical planning and delivery across clinical programs and lead clinical developments plans within oncology.
Responsibilities:
- Represent Oncology Biostatistics externally and serve as project statistician for an oncology asset
- Lead statistical assessment in business development opportunities
- Lead statistical strategy for study design, analysis, reporting, and interpretation
- Represent GSK-Oncology Biostatistics at scientific meetings and presentations
- Influence planning and decision-making strategy over assets through building and maintaining effective business relationships with key functions
- Contribute to and influence the strategic direction of the asset development and regulatory submission via rigorous and robust statistical knowledge
- Ensure state-of-the-art expertise on key methodological aspects of drug development in statistics
Requirements:
- MS/MSc in Statistics (or related quantitative field) with at least 8+ years post-degree experience
- Experience preparing regulatory documents and interacting with regulators
- Solid tumor Oncology experience required
- Experience supporting Oncology Clinical development in pharmaceutical, biotech, or CRO settings
- Demonstrated delivery of fit-for-purpose statistical solutions
- Proficiency in R and/or Python; working knowledge of SAS is a plus
- Strong communication and stakeholder-management skills, with demonstrated ability to influence across functions in a matrix environment
- Highly organized, self-directed, and able to manage multiple priorities across projects
Preferred Qualifications:
- PhD preferred with minimum of 8+ years post-degree experience
- Lung/NSCLC experience strongly preferred
- Hands-on expertise in statistical modeling and innovative design and methods (e.g., Bayesian approaches)
- Thorough knowledge of the drug development process including late-phase development, registration activities, and oncology regulatory expectations
- Familiarity with causal inference and/or AI/ML methods, and interest in applying these approaches (when appropriate) to clinical and/or real-world data
- Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence
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