Senior Director Biostatistics

Site Name: UK – London – New Oxford Street, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Nov 26 2025 Company Overview 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. GSK has kicked off 2025 with impressive growth in sales, profits, and earnings. We anticipate five major new FDA product approvals and 15 phase III/pivotal study readouts over the next two years. So far, we have secured two FDA approvals, with three more expected later this year. By uniting science, technology, and talent, we are committed to getting ahead of disease together. Job Purpose GSK is seeking an outstanding and visionary leader to lead Biostatistics activities for medicines in late-stage development to treat metabolic dysfunction-associated steatohepatitis (MASH) and Alcohol Related Liver Disease (ALD). You will design and guide statistical strategies across clinical development and post-approval launch activities. You will partner with cross-functional teams including clinical, regulatory, and medical. You will coach and grow a talented team and help shape how we use data to make better decisions. This role offers career growth, visible impact, and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK’s US(PA ) or UK (Stevenage or GSK HQ) sites. Key Responsibilities: Lead statistical planning and design for phase II and phase III clinical trials for medicines in development to treat MASH and ALD. Provide statistical approval of trial protocols, analysis plans, and regulatory submissions. Oversee clinical data analysis, interim reviews, and final study reporting. Advise cross-functional teams on strategy, risk, and interpretation of results. Line-manage and mentor statisticians to build capability. Direct experience engaging with regulatory agencies and preparing regulatory statistical documentation. Represent programs in senior governance meetings and external regulatory interactions. Why you? Basic Qualifications: MSc or equivalent in Statistics, Biostatistics, Mathematics, or related quantitative discipline. Significant experience in statistical support of clinical development, preferably within ALD and/or Metabolic disease in the pharmaceutical/biotech industry. Expertise in the design, analysis, and interpretation of clinical studies, including biomarker development. Demonstrated success leading and developing high-performing teams in a global environment. Strong track record of methodological innovation and application of advanced quantitative approaches (e.g., Bayesian methods, model-informed drug development). Experience influencing cross-functional teams and senior decision-makers. Excellent communication skills, with the ability to articulate complex statistical concepts to diverse audiences. Experience working with regulatory authorities and external collaborators is strongly preferred. Preferred Qualifications: PhD in Statistics, Biostatistics, or related field. Background in therapeutic areas relevant to MASH and ALD. Track record of building statistical strategy across global development programs. Familiarity with statistical programming in R and validated analysis environments. 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. 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. 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