Senior Scientist, Statistical Programming, SDTM (Hybrid)

A Senior Statistical Programmer in the Biostatistics and Research Decision Sciences division oversees quality management for submission data standards in global regulatory applications for drug and vaccine development. The role involves planning submission activities, coaching project teams, collaborating with external vendors, and ensuring compliance with industry standards like SDTM and ADaM. Key responsibilities include preparing for regulatory meetings, guiding deliverable creation using tools like Pinnacle 21, and driving continuous improvement in electronic submission processes.