Statistics Director, Oncology
GSK
Summary
GSK Oncology is committed to discovering and developing new therapies with the potential to change the lives of patients with cancer. The Oncology Clinical Development Statistics group is seeking exceptionally talented Statisticians to provide end-to-end statistical leadership across oncology evidence generation from early development through registration and lifecycle support using innovative trial designs and modern statistical methods (including simulation, interim strategies, Bayesian approaches, and external/real-world data) to inform key development decisions.
Job description
You will lead statistical planning and delivery across clinical programs and lead clinical development plans within oncology. You will work closely with clinical, regulatory, safety, data science and commercial teams. You will design robust clinical trials and analyses that shape development decisions and regulatory strategy. You will drive methodological innovation and mentor colleagues.
Responsibilities
- Represent Oncology Biostatistics externally as appropriate and may serve as project statistician for an oncology asset.
- Provide Stat leadership for global regulatory submissions in oncology assets.
- Lead statistical assessment in business development opportunities.
- 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.
- 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.
Basic Qualifications
- 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 to clinical and/or real-world data.
- Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives.
Requirements
- MS/MSc in Statistics or related quantitative field
- 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
- Ability to influence across functions in a matrix environment
- Highly organized, self-directed, able to manage multiple priorities
- PhD preferred with minimum of 8+ years post-degree experience
- Lung/NSCLC experience strongly preferred
- Hands-on expertise in statistical modeling and innovative design methods (e.g., Bayesian approaches)
- Thorough knowledge of drug development process including late-phase development, registration activities, and oncology regulatory expectations
- Familiarity with causal inference and/or AI/ML methods
Benefits
- Health care
- Insurance benefits
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver leave
- Paid parental leave
- Paid medical leave
- Annual bonus
- Share based long term incentive program
Company overview
GSK plc (formerly GlaxoSmithKline) is a British multinational pharmaceutical and biotechnology company headquartered in London, England. Founded in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham, GSK has grown to become one of the world's leading healthcare companies with operations in over 150 countries. The company specializes in researching, developing, and manufacturing prescription medicines, vaccines, and consumer healthcare products. GSK's therapeutic areas include respiratory diseases, HIV/AIDS, oncology, immunology, and infectious diseases. The company is particularly renowned for its vaccine portfolio and has been at the forefront of developing treatments for major global health challenges. With approximately 70,000 employees worldwide, GSK maintains a strong commitment to scientific innovation and has a significant presence in key markets including the United States, Europe, and emerging economies. The company's mission is to unite science, technology, and talent to get ahead of disease together, aiming to positively impact the health of 2.5 billion people by the end of the decade.