Associate Director, Real World Biostatistics

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D


Position Summary

The Associate Director is a global role responsible for driving strategic initiatives for value delivery. The role applies advance biostatistical methods and AI tools to real world data (RWD), in order to generate real world evidence (RWE) for informing trial design, regulatory submissions, reimbursement and safety signals.

The strategic role works in close partnership with cross-functional teams across GSK and is tasked with leading the development and optimization of RWE strategies for priority assets. The role is pivotal in ensuring data-driven decision-making generates the best evidence package for approvals.

Key Responsibilities:

Biostatistics:

• As a Project Biostatistician, lead the design and analysis of non-interventional studies, aligning with cross functional teams, managing timelines, and ensuring methodological rigor and quality control.
• Apply statistical and RWD expertise to guide the selection and appropriate use of complex health data sets, co-develop variable definitions, code lists, and author technical specification documents.
• Develop and refine statistical analysis plans, conduct complex statistical analyses, including for example causal inference, comparative effectiveness, target trial emulation, and communicate findings to internal and external stakeholders.

Strategic Initiatives:

• Serve as a senior-level RWB consultant within matrix teams, leveraging in-depth expertise on assigned assets.

• Serve on enterprise level strategic initiatives, for example Disease Area Acceleration Teams, for organizational deliverables.

Communication:

• Present statistical analyses and insights effectively to internal stakeholders and external audiences, including conferences and publications, showcasing the value of biostatistical contributions.
• Engage in strategic communication to reinforce the role of biostatistics in driving innovation and decision-making across the organization.

Methodological Development and Innovation:

• Stay informed on emerging industry trends and incorporate cutting-edge biostatistical methods to improve study designs and analytics.
• Conduct methodological research and contribute to the development/application of new analytical techniques.

Regulatory Support and Compliance:

• Provide biostatistical expertise on RWD during regulatory submissions, preparing for meetings and addressing regulatory queries to ensure compliance with industry standards.
• Stay current with regulatory guidance on the use of RWD for decision-making and advise on statistical approaches aligned with regulatory expectations.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Ph.D. in Statistics, Data Science, Epidemiology, or related field with 6+ years of experience (or Master’s degree with 8+ years) in the pharmaceutical/biotech industry, preferably in real-world evidence, epidemiology, or health outcomes research.
• Experience with drug development processes, with demonstrated ability to apply innovative statistical thinking to achieve project and business objectives.
• Experience using RWD (e.g., electronic health records, insurance claims, registries) and applying observational study designs and biostatistical principles in clinical/epidemiological research.
• Experience with programming languages R and SQL, with applied experience working with observational datasets.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrated ability to manage complex projects and deliver high-quality results in dynamic environments.
• Contributions to methodological research and publications in the field of biostatistics and real-world data analytics.
• Strong communication and interpersonal skills to effectively convey complex statistical concepts.
• Fluency in written and spoken English.
• Experience working within regulatory frameworks related to RWD.
• Experience in advanced biostatistical techniques, including causal inference, comparative effectiveness, time to event analysis, longitudinal and predictive modelling, and external control arms.
• Familiarity with machine learning techniques and applications in real-world data.

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Skills

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 we’re 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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