GlaxoSmithKline
Director, Real-World Biostatistics
GlaxoSmithKline, Durham, North Carolina, United States, 27703
The
Director, Real-World Biostatistics
(RWB) 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).
The Director will design and analyze RWD studies and other observational studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, clinical outcomes assessment, longitudinal and predictive modelling, and target trial emulation, while also mentoring staff assigned to these projects.
Key Responsibilities Biostatistical and Methodologic Support
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 Master’s + 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.
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 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.
#J-18808-Ljbffr
Director, Real-World Biostatistics
(RWB) 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).
The Director will design and analyze RWD studies and other observational studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, clinical outcomes assessment, longitudinal and predictive modelling, and target trial emulation, while also mentoring staff assigned to these projects.
Key Responsibilities Biostatistical and Methodologic Support
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 Master’s + 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.
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 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.
#J-18808-Ljbffr