Associate Director or Principal Statistician, Real-World Biostatistics

Associate Director / Principal Statistician

Real-World Biostatistics (RWB) (multiple roles available)

The Associate Director or Principal Statistician RWB is a global role responsible for driving strategic initiatives for value delivery. These roles apply advance biostatistical methods and AI tools to real world data (RWD), 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 the 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) for Associate director (or for Principal Statistician PhD with 4+ years / Master’s degree with 3+ years) in the pharmaceutical/biotech industry, preferably in real-world evidence, epidemiology, or health outcomes research.

• Experience working with drug development processes utilizing statistical skills 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.

• Proficiency in programming languages R and SQL, with applied experience working with observational datasets.

• Experience contributing to methodological research and publications in the field of biostatistics and real-world data analytics.

Preferred Qualifications:

• 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 analysis.

• Demonstrated ability to manage complex projects and deliver high-quality results in dynamic environments.

• Strong communication and interpersonal skills to effectively convey complex statistical concepts.

• Fluency in written and spoken English.

Why Join Us?

At GSK, we are united by a shared purpose: helping people do more, feel bett