Principal Statistician, Real-World Biostatistics

WISE Campaign; City Of London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in London seeks a Principal Statistician to drive strategic initiatives and apply advanced biostatistical methods. The role involves leading non-interventional studies, collaborating with cross-functional teams, and ensuring regulatory compliance. Ideal candidates will have a PhD or Master's in a relevant field and extensive experience in the pharmaceutical industry. Join us to contribute to life-changing medicines.

Qualifications

• PhD or Master's degree in Statistics, Data Science, Epidemiology, or related field.
• 3+ years work experience in the pharmaceutical/biotech industry, preferably in RWE.
• Experience in programming languages R and SQL, working with observational datasets.

Responsibilities

• Lead the design and analysis of non-interventional studies.
• Develop statistical analysis plans and conduct complex statistical analyses.
• Provide biostatistical expertise during regulatory submissions.

Skills

Statistical analysis

Data science

Epidemiology

Communication skills

Programming in R

Programming in SQL

Education

PhD or Master's degree in a related field

Tools

R

SQL

Job description

Overview

The Principal Statistician RWB is a global role responsible for driving strategic initiatives for value delivery. This role applies advanced 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.

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 causal inference, comparative effectiveness, target trial emulation, and communicate findings to internal and external stakeholders.

Strategic Initiatives

• Serve as a 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:

• PhD or Master\'s degree in Statistics, Data Science, Epidemiology, or related field.

• PhD with 3+ years work experience / Master\'s degree with 5+ 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.

• Experience in programming languages R and SQL, 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 better, and live longer. As Associate Director/Principal Statistician of Real-World Biostatistics, you will play a key role in advancing pharmaceutical science and contributing to the development of life-changing medicines. GSK offers opportunities to work on cutting-edge projects, collaborate with talented teams, and drive innovation in healthcare.

Join us and make an impact. Apply today!

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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