
This hybrid role within the Biostatistics and Research Decision Sciences department focuses on leading quality management for regulatory submission data standards in drug and vaccine development. The position involves overseeing SDTM deliverables, coaching project teams, and collaborating with global stakeholders to ensure compliance with CDISC standards and FDA requirements. Key responsibilities include preparing for regulatory meetings, guiding the use of submission tools like Pinnacle 21, and driving continuous improvement of electronic submission processes. The role appeals to professionals seeking to impact global human health through high-level strategic initiatives and cross-functional collaboration. It offers a flexible hybrid work arrangement with opportunities for professional growth in a culture that values innovation and diverse perspectives.






