Job Purpose:
The Director of Biostatistics for Real-World Data, Measurement, and Analytics (RWDMA) is a key role focused on advancing real-world data (RWD) projects and initiatives within the organization. This position requires providing deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products.
The 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, while also managing and mentoring staff assigned to these projects.
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.
- Project Management and Staff Mentorship:
- Manage assigned 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, and coordinate across departments (clinical, regulatory, and data management).
- 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 during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards while offering statistical guidance for organizational decision-making processes.
Basic Qualifications:
- Ph.D. in Biostatistics, Statistics, Epidemiology or related disciplines.
- 8+ years of experience in advanced biostatistical techniques, including those associated with causal inference and comparative effectiveness, longitudinal and predictive modeling, precision medicine and evidence synthesis.
- Proficiency 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 staff and projects, delivering quality results in complex environments.
Preferred Qualifications:
- Experience in methodological research with contributions to publications in real-world data analytics.
- Expertise in machine learning and artificial intelligence techniques for enhancing data analytics.
- Excellent communication and interpersonal skills for conveying complex statistical concepts effectively.
#LI-GSK*
Please visit GSK US Benefits Summary to 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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