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Site Name: USA - Pennsylvania - Philadelphia, Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - London, USA - Massachusetts - Waltham, USA - North Carolina - Durham
Posted Date: Oct 16 2025
Director, Real-World Biostatistics (RWB) The Director, Real-World Biostatistics is a key role focused on advancing strategy and methodology in the entire course of drug/vaccine development using real-world data (RWD) within the enterprise. This position requires deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products, primarily in the respiratory, immunology and inflammation research unit (RIIRU).
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 internal and external stakeholders.
Apply fit-for-purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
Therapy Area Knowledge
Understand RIIRU assets to apply appropriate tools (e.g. variable definitions, code lists) and data sources, and leverage hands-on 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 assigned assets and act as senior-level RWB consultant on matrix teams.
Project Management and Staff Mentorship
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).
Communication and Strategic Initiatives
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.
Methodological Development and Innovation
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.
Regulatory Support and Compliance
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 the use of RWD for regulatory decision-making.
Why you? Basic Qualifications
Ph.D. in Statistics, Data Science, 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 in 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 Qualifications
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.
Please contact GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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Site Name: USA - Pennsylvania - Philadelphia, Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - London, USA - Massachusetts - Waltham, USA - North Carolina - Durham
Posted Date: Oct 16 2025
Director, Real-World Biostatistics (RWB) The Director, Real-World Biostatistics is a key role focused on advancing strategy and methodology in the entire course of drug/vaccine development using real-world data (RWD) within the enterprise. This position requires deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products, primarily in the respiratory, immunology and inflammation research unit (RIIRU).
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 internal and external stakeholders.
Apply fit-for-purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
Therapy Area Knowledge
Understand RIIRU assets to apply appropriate tools (e.g. variable definitions, code lists) and data sources, and leverage hands-on 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 assigned assets and act as senior-level RWB consultant on matrix teams.
Project Management and Staff Mentorship
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).
Communication and Strategic Initiatives
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.
Methodological Development and Innovation
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.
Regulatory Support and Compliance
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 the use of RWD for regulatory decision-making.
Why you? Basic Qualifications
Ph.D. in Statistics, Data Science, 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 in 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 Qualifications
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.
Please contact GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
#J-18808-Ljbffr