Senior Manager, Clinical Programmer

Bachelor's degree in Computer Science, Statistics, or related discipline. Minimum 8 years experience in clinical programming. Minimum 3 years experience in vaccine clinical studies with BLA e-submission experience. Proficient in SAS. Experience with R or Python is a plus. Strong knowledge of CDISC standards (SDTM, ADaM). Strong knowledge of FDA OVRR guidance. Familiarity with ICH, GCP, clinical research processes, and regulatory requirements. Detail-oriented with excellent problem-solving abilities. Strong communication and coordination skills. Ability to manage multiple priorities and vendors effectively.

Develop, validate, and maintain programs for tables, listings, and figures (TLFs). Develop, review, and validate CDISC-compliant e-submission components. Partner with statisticians on mock tables. Oversee programming vendors. Collaborate with Data Management, Clinical Operations, and Clinical/Regulatory Writing. Perform ad hoc analyses. Compile data for integrated submissions (ISS/ISE). Drive standardization of programming rules and support visualization.