Director, Real-World Biostatistics

General Description

The Director, Real‑World Biostatistics at GSK leads the development and application of real‑world data (RWD) strategies across the drug and vaccine development lifecycle, primarily within the oncology research unit.

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Key Responsibilities

• Lead and oversee the execution of real‑world studies, ensuring methodological rigor, quality control, and regulatory adherence.
• Create and refine statistical analysis plans; conduct complex statistical analyses and convey findings to stakeholders.
• Apply fit‑for‑purpose non‑interventional statistical methods tailored to specific study objectives.
• Interpret and provide insights from RWD, ensuring robust data interpretation.
• Mentor junior staff, guiding their development through training and professional growth opportunities.
• Lead statistical efforts, manage timelines, resources, and cross‑department coordination (e.g., epidemiology, health economics).
• Engage in strategic communication with external audiences, presenting analyses at conferences, in publications, and in stakeholder meetings.
• Stay informed on industry and regulatory trends, incorporating emerging biostatistical methods into study designs and analytical techniques.
• Provide biostatistical expertise on RWD during regulatory submissions, meeting preparations, and addressing queries to meet regulatory standards.

Basic Qualifications

• Ph.D. in Biostatistics, Statistics, Epidemiology or related discipline with 8+ years experience (or Master’s plus 10+ years) in pharmaceutical/biotech industry, preferably in real‑world evidence, epidemiology, or health outcomes.
• Experience with drug development processes and strategies, leveraging innovative statistical skills to meet project objectives.
• Experience leading pharmacoepidemiology and/or health outcomes analytics using RWD (electronic health record, insurance claims, registries) and applying observational study design and biostatistical principles.
• Proficiency in programming languages (e.g., R, Python) and applied experience with observational data.
• Experience working according to regulatory requirements pertaining to RWD and clinical trials.
• Project management experience, delivering results in matrixed environments.
• Methodological research experience with contributions to publications in real‑world data analytics.

Preferred Qualifications

• Experience with causal inference methodologies (propensity score, doubly‑robust estimations, target maximum likelihood estimation, principal stratification, instrumental variable approaches, time‑varying exposure methods).
• Experience in time‑to‑event analysis for non‑randomized studies.
• Experience in machine learning techniques.
• Excellent communication and interpersonal skills for conveying complex statistical concepts effectively.
• Fluency in written and spoken English.

Benefits and Compensation

• Salary range: $174,900 to $291,500 (geographically dependent).
• Annual bonus and eligibility for share‑based long‑term incentive program.
• Health care and other insurance benefits for employee and family.
• Retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. xwzovoh

GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, disability, genetic information, military service, or any other protected status under applicable law.