Associate Director, Real World Biostatistics

GSK; Upper Providence (Delaware County); On-site; USD 180,000 - 240,000; Full time

Job summary

GSK is seeking an Associate Director of Biostatistics to lead strategic real-world evidence initiatives using RWD and AI tools. You will design non-interventional studies, guide cross-functional teams, and support regulatory submissions with rigorous statistical methodology.

Ideal candidates hold a PhD in statistics or related field with extensive pharma experience, strong R/SQL programming skills, and excellent communication to present complex analyses to diverse audiences.

Qualifications

• 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.
• Experience with real-world data (RWD) and applying observational study designs and biostatistical principles in clinical/epidemiological research.
• Experience using R and SQL with applied experience working with observational datasets.
• Fluency in written and spoken English.

Responsibilities

• Lead the design and analysis of non-interventional studies, aligning with cross functional teams, managing timelines, and ensuring methodological rigor and quality control.
• Develop and refine statistical analysis plans, conduct complex statistical analyses including causal inference and comparative effectiveness, and communicate findings to stakeholders.
• Serve as a senior-level RWD consultant within matrix teams and participate in enterprise level strategic initiatives.
• Provide biostatistical support on regulatory submissions, preparing for meetings and addressing regulatory queries.
• Stay informed on emerging industry trends and contribute to methodological development and innovation.

Skills

Continuing Learning

Influencing Without Authority

Leadership

Problem Solving

Education

Ph.D. in Statistics, Data Science, Epidemiology, or related field

Master's degree in Statistics, Data Science, Epidemiology, or related field

Tools

R

SQL

Job description

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.

Find out more: 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.

Why you?

Basic Qualifications

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.

Skills

Continuing Learning, Influencing Without Authority, Leadership, Problem Solving,

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