Associate Director or Principal Statistician, Real-World Biostatistics

Associate Director or Principal Statistician, Real-World Biostatistics (RWB). Global role responsible for driving strategic initiatives for value delivery. 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. Works in cross-functional teams to lead the development and optimization of RWE strategies for priority assets. Aims to ensure data-driven decision-making generates the best evidence package for approvals.

• Biostatistics: Lead the design and analysis of non-interventional studies, align with cross-functional teams, manage timelines, ensure 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 analyses (e.g., causal inference, comparative effectiveness, target trial emulation), and communicate findings to internal and external stakeholders.

• Serve as a senior-level RWB consultant within matrix teams, leveraging in-depth expertise on assigned assets.
• Participate in enterprise-level strategic initiatives (e.g., Disease Area Acceleration Teams) for organizational deliverables.

• 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.

• 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.

• 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.

• 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 PhD with 4+ years / Master’s with 3+ years for Principal Statistician, 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 biostatistics and real-world data analytics.

• Experience 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.
• Ability to manage complex projects and deliver high-quality results in dynamic environments.
• Strong communication and interpersonal skills to convey complex statistical concepts.
• Fluency in written and spoken English.

At GSK, we unite science, technology and talent to get ahead of disease together. As Associate Director/Principal Statistician of Real-World Biostatistics, you will contribute to advancing pharmaceutical science and 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!

The US annual base salary for new hires ranges from $108,750 to $181,250. The salary may vary by location, skills, experience, and market rate. This role includes an annual bonus and eligibility to participate in the long-term incentive program. Available benefits include health care and other insurance, retirement benefits, paid holidays, vacation, and parental/medical leave. Details are provided during recruitment.

For more information on benefits, please visit the GSK US Benefits Summary.

GSK is an Equal Opportunity Employer. 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, military service, or any basis prohibited by law.

GSK does not accept referrals from employment businesses/agencies without prior written authorization. See posted job for more details.