GSK · 14 hours ago
Director, Real-World Biostatistics
Collegeville, PA
Full-time
Onsite
Director/Executive
$175K/yr - $292K/yr
8+ years expGSK is a global biopharma company focused on advancing health through innovative medicines and vaccines. They are seeking a Director of Real-World Biostatistics to provide biostatistical expertise and strategic insight in drug and vaccine development using real-world data, while also mentoring junior staff and engaging in methodological innovation.
BiotechnologyHealth CarePharmaceutical
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 internal and external stakeholders
Apply fit for purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation
Understand RU/assets to apply appropriate tools (e.g., variable definitions, code lists) and data sources and leverage hands on with RWD expertise to guide the selection and appropriate use of complex health data sets, including experience authoring technical specification documents
Develop in-depth knowledge on the assigned asset(s) and act as senior-level RWB consultant on matrix teams
Mentor junior staff, guiding and developing their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing, continuous learning, and an innovative and collaborative environment
Lead statistical efforts for assigned projects, manage timelines, resources, quality control, and coordinate across departments (e.g. epidemiology, health economics and outcomes research, clinical)
Engage in strategic communication within the organization and with external audiences presenting statistical analyses and insights clearly and effectively at conferences, in publications, and during key stakeholder meetings, reinforcing the value of biostatistical contributions
Stay informed on industry trends, incorporate emerging biostatistical methods to enhance study designs and analytics, and participate in methodological research for the development of analytical techniques
Provide biostatistical expertise on RWD during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards while offering statistical guidance for organizational decision-making processes
Stay informed with guidance documents from regulators to industry on use of RWD for regulatory decision-making
Qualification
Required
Ph.D. in Biostatistics, Statistics, Epidemiology or related disciplines with 8+ years (or Masters plus 10+ years) of working within the pharmaceutical/biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas)
Experience working with drug development processes and strategies, utilizing innovative statistical skills to meet project and/or business objectives
Experience leading pharmacoepidemiology and/or health outcomes analytics using RWD(e.g, electronic health record; insurance claims; registries) and applying observational study design and biostatistical principles to clinical/epidemiological research
Experience in programming languages (e.g., R, Python) and applied experience with observational data
Experience in working according to regulatory requirements pertaining to RWD and clinical trials
Experience in managing projects, delivering results in matrixed environments
Experience in methodological research with contributions to publications in real-world data analytics
Preferred
Experience in causal inference methodology such as propensity score based approaches, doubly-robust estimations including target maximum likelihood estimation (TMLE), principal stratification/instrumental variable approaches, methods for time-varying exposures
Experience in time-to-event analysis in the setting of non-randomized studies
Experience in machine learning
Excellent communication and interpersonal skills for conveying complex statistical concepts effectively
Fluency in written and spoken English
Benefits
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
South China Morning Post
2026-01-08
2026-01-07
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