Director, Biostatistics

Director, Real-World Biostatistics

The Director, Real-World Biostatistics is a key role focused on advancing strategy and methodology throughout drug/vaccine development using real‑world data (RWD) within the enterprise. The position requires deep biostatistical expertise, strategic insight, and support for methodological innovation to enhance development and commercialization of pharmaceutical products, primarily in the oncology research unit.

• Biostatistical and Methodologic Support
  Lead and oversee execution of real‑world studies, ensuring methodological rigor, quality control, and regulatory adherence.
  Create and refine statistical analysis plans, conduct complex analyses, and convey findings to stakeholders.
• Therapy Area Knowledge
  Understand assigned assets to select appropriate tools and data sources; author technical specification documents and provide senior‑level RWD consulting to matrix teams.
• Project Management and Staff Mentorship
  Mentor junior staff, guiding their development through training and professional growth; lead statistical efforts for projects, manage timelines, resources, and coordinate with epidemiology, health economics, outcomes research, and clinical teams.
• Communication and Strategic Initiatives
  Present statistical analyses and insights clearly at conferences, in publications, and during stakeholder meetings to reinforce the value of biostatistical contributions.
• Methodological Development and Innovation
  Stay informed on industry trends, incorporate emerging biostatistical methods to enhance study designs and analytics, and participate in methodological research.
• Regulatory Support and Compliance
  Provide biostatistical expertise on RWD for regulatory submissions, meeting preparations, and address queries to ensure alignment with regulatory standards.

• Ph.D. in Biostatistics, Statistics, Epidemiology, or related discipline with 8+ years of experience in the pharmaceutical/biotech industry (or Masters plus 10+ years).
• Experience with drug development processes and strategies, applying innovative statistical skills to meet project and business objectives.
• Experience leading pharmacoepidemiology and/or health outcomes analytics using RWD (EHR, insurance claims, registries) and applying observational study design and biostatistical principles.
• Proficiency in R or Python and applied experience with observational data.
• Experience working according to regulatory requirements pertaining to RWD and clinical trials.
• Experience managing projects and delivering results in matrixed environments.
• Experience in methodological research with contributions to publications in real‑world data analytics.

• Causal inference methodology such as propensity score, doubly‑robust estimations, TMLE, principal stratification, instrumental variable approaches, time‑varying exposure methods.
• Time‑to‑event analysis in non‑randomized studies.
• Experience in machine learning.
• Excellent communication and interpersonal skills for conveying complex statistical concepts effectively.
• Fluency in written and spoken English.
• Candidate location:
  Cambridge, MA;
  Waltham, MA;
  Rockville, MD; or San Francisco, CA. Salary ranges $174,900–$291,500 with annual bonus and share‑based long‑term incentive program; benefits include health care, retirement, paid holidays, vacation, and caregiver/parental and medical leave.

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

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