GlaxoSmithKline
Senior Director Biostatistics
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
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.
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.
Equal Opportunity Employer 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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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.
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.
Equal Opportunity Employer 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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