Senior Director Biostatistics

GSK, Plc.•Collegeville, PA

34d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume