Job description
Site Name:USA - Pennsylvania - Upper Providence, Cambridge MA, GSK HQ, Philadelphia Walnut Street, USA - North Carolina - Durham
Posted Date:Mar 7 2025
Position Summary:
The Associate Director of Biostatistics for Real-World Data, Measurement, and Analytics (RWDMA) will be instrumental in driving real-world data (RWD) projects and initiatives. This role requires providing biostatistical expertise and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products. Collaborating closely with stakeholders in R&D and Medical Affairs, the Associate Director will design and analyze RWD studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, digital measurement, clinical outcomes assessment, longitudinal and predictive modeling, and evidence synthesis.
Key Responsibilities:
Biostatistical and Methodologic Support:
Lead and oversee the execution of real-world studies, ensuring methodological rigor and regulatory adherence.
Create and refine statistical analysis plans, conduct complex statistical analyses, and convey findings to internal and external stakeholders.
Apply advanced statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
Engage in strategic communication initiatives to effectively promote and disseminate biostatistical deliverables both within the organization and to external stakeholders.
Promote an innovative and collaborative environment that encourages knowledge transfer and continuous learning within the team.
Project Leadership and Collaboration:
Serve as the statistical leader on assigned projects, managing timelines, resources, and deliverables to meet project goals.
Collaborate effectively with clinical, RWD, regulatory, data management, and programming teams to ensure statistical strategies align with overarching project goals.
Provide statistical expertise in interactions with regulatory bodies, including meeting preparations, query responses, and submission support.
Act as a subject matter expert in statistical methodology, delivering insights and guidance to support organizational decision-making.
Methodological Development and Innovation:
Stay informed on industry trends and incorporate emerging biostatistical methods to enhance study designs and analytics.
Participate in methodological research, contributing to the development of analytical techniques and addressing statistical challenges.
Regulatory Support and Compliance:
Provide biostatistical expertise during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards.
Contribute as a subject matter expert, offering statistical guidance for organizational decision-making processes.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Ph.D. in Biostatistics, Statistics, Epidemiology or a related field with 6+ years’ experience in the pharmaceutical, biotechnology, or healthcare industry, focusing on real-world data analytics.
Experience in advanced biostatistical methods, including those associated with causal inference and comparative effectiveness, longitudinal and predictive modeling, precision medicine and evidence synthesis.
Experience with statistical programming languages (e.g., R, Python) and applied experience with observational data.
Experience with regulatory requirements for clinical trials and real-world data analysis.
Previous leadership in managing or leading statistical projects, delivering high-quality results in a dynamic environment.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Experience in methodological research with contributions to publications in real-world data analytics.
Experience using artificial intelligence and machine learning methods in real-world data applications.
Excellent communication skills, with the ability to effectively convey complex statistical concepts to a variety of stakeholders.
Please visit GSK US Benefits Summaryto learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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