Statistics Leader Associate Director of Statistics

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 generationfrom early development through registration and lifecycle supportusing innovative trial designs and modern statistical methods (including simulation interim strategies Bayesian approaches and external/real-world data) to inform key development decisions.


Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include the following:

• 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

Why You
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• 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

Preferred Qualifications
If you have the following characteristics it would be a plus

• PhD

• Experience supporting Oncology Clinical development in pharmaceutical biotech or CRO settings.

• Working knowledge of SAS

• Hands-on expertise in statistical modeling and innovative 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.

• 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

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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