Director of Real - World Biostatistics advancing strategy and methodology using real - world data within biopharma. Leading studies, mentoring staff, and ensuring regulatory compliance.
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Responsible for global CMC regulatory activities for assigned GSK projects. Engaging in strategy development and ensuring regulatory compliance for product lifecycle management.
Director of Medical Affairs overseeing early development in HIV treatment at ViiV Healthcare. Provide strategic insights into R&D and collaborate with stakeholders for project success.
Associate Director, Statistical Pharmacogenetics at GSK, conducting analyses on clinical trial data. Collaborating across teams to deliver pharmacogenetic insights in the development process.
Data Curation Developer at GSK preparing high - quality data assets for R&D analysis through collaboration and technical expertise. Handle diverse datasets and ensure compliance with privacy and analysis standards in a hybrid work environment.
Director in the Translational & Clinical Genetics team at GSK, providing strategic leadership and expertise in genetics for drug development.
Associate Director/Principal Statistician driving strategic biostatistical initiatives in real - world evidence. Collaborating across teams to enhance decision - making for regulatory submissions and trial design.
Senior Director overseeing Medical Information and Content Approval at GSK. Leading operational excellence and ensuring compliance in content approval processes across the organization.
GCP Quality Auditor performing audits to ensure compliance with GSK policies and Good Clinical Practices. Responsibilities include documenting findings, maintaining knowledge of GCP legislation, and supporting regulatory inspections.
Diagnostics Leader at GSK focusing on precise medicine innovations through diagnostics development. Overseeing global drug registration and collaboration across therapeutic areas with a team of senior talent.
Senior Regulatory Specialist managing regulatory information and support for GSK's product portfolio. Collaborating across teams to ensure compliance and quality in regulatory data management.
Senior Regulatory Specialist managing CMC new files and CTA assignments for Pharma and Vaccines products. Working with colleagues in Global Manufacturing & Supply to ensure regulatory compliance.