About the Role
You will lead statistical programming activities for clinical trials from Phase I through regulatory submission. You will design, validate, and maintain SAS programs; produce SDTM, ADaM, and TLF deliverables; and ensure compliance with CDISC standards and FDA/EMA guidelines. You will partner with cross-functional stakeholders, review deliverables, mentor junior programmers, support submissions, improve processes, and oversee outsourced programming work.
Requirements
•Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field
•Minimum 10 years of statistical programming experience in pharmaceutical, biotechnology, or CRO industries
•Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph
•Strong experience with CDISC SDTM and ADaM standards
•Familiarity with define.xml and Pinnacle 21
•Experience supporting FDA and/or EMA regulatory submissions
Responsibilities
•Lead the design, development, validation, and maintenance of SAS programs for SDTM, ADaM, and TLF deliverables
•Ensure compliance with CDISC standards, FDA/EMA guidelines, and internal SOPs
•Collaborate with Biostatisticians, Data Managers, and Clinical Operations teams to define requirements and timelines
•Perform quality control and peer reviews of deliverables
•Serve as the statistical programming technical subject matter expert and mentor junior programmers
•Support clinical study reports, regulatory submission packages, and responses to regulatory agencies
•Develop and refine departmental processes, templates, and tools
•Contribute to vendor oversight and technical leadership for outsourced programming activities
Benefits
•Company-paid healthcare
•Flexible spending accounts
•Voluntary life insurance
•401K matching
•Uncapped vacation
•Onsite gym
•Onsite dining
