Oncology Statistics Leader/associate Director

**Site Name**: USA - Pennsylvania - Upper Providence, GSK HQ, Home Worker - USA, Stevenage, Waltham
**Posted Date**: Feb 4 2025

The Oncology Clinical Development Statistics group has a **Statistics Leader/Associate Director** opportunity available to support assets within the Oncology disease area, providing statistical and strategic insight into the clinical development plan and design of end-to-end development strategies. This begins with early first in human trials, all the way through to late phase drug development. The team strive to use novel clinical trial designs and innovative statistical methodologies, including Bayesian techniques, to quantify risk across an entire program and enable smart decision making on where to invest to improve the probability of study and program success.

**Key Responsibilities**:

- Leading clinical development strategy of specific indication and projects
- Partner with clinical matrix team across the clinical development organization to drive the early phase and/or later phase asset development
- Design and analysis of platform/basket trial
- Collaborate with project statisticians to identify the opportunities to align and harmonize the designs and analyses for each oncology indication
- Developing knowledge in global regulatory submissions across assets and countries with different mechanism of actions in multiple indications of oncology.
- Serve as statistical expert for internal and external collaborators, investigators, consultants, and contract resources
- Lead statistical assessment in the business development opportunities
- Represent GSK-Oncology Biostatistics at scientific meetings and presentations
- Influence planning and decision-making strategy over a portfolio of 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 all methodological aspects of drug development in statistics

**Basic Qualifications**:

- PhD in Statistics or related discipline with 4+ years of experience working as a Statistician within a CRO, Clinical Trial, or Academic setting in the Pharmaceutical Industry, or MS in Statistics or related discipline with 7+ years of experience working as a Statistician within a CRO, Clinical Trial, or Academic setting in the Pharmaceutical Industry
- Experience designing and analyzing oncology trials
- Experience implementing innovative methods, such as Adaptive Design, Machine Learning, and Trial Simulation, using SAS, R or other professional software
- Experience with the clinical development process through commercialization

**Preferred Qualifications**:

- Experience with oncology statistical methodologies, either emerging or implemented, to maximize program success
- Familiarity with regulatory interactions and pathways
- Track record of strong statistical contributions and accomplishments in clinical drug development, with a broad knowledge of all phases of drug development (pre-clinical; Phase I-IV).
- Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.
- Self-motivated and independent worker
- Strong time management skills; able to effectively organize and manage a variety of tasks across different projects
- Excellent interpersonal and communication skills.

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 special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified