Manager, Statistical Programming (Must require skills: SDTM datasets, ADaM datasets, TLFs)
Core
Leads a global team of Statistical Programmers to deliver high-quality SDTM, ADaM, and TLF datasets for clinical development projects, ensuring adherence to timelines, budgets, and industry standards.
Role type
Senior IC Manager, Statistical Programming
Builds
Regulatory submission packages (SDTM, ADaM, TLFs) for clinical trials
Domain
Clinical Research / Biostatistics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Statistical Programming (SAS, R), SDTM/ADaM/TLF standards, Team Leadership, Project Management, Quality Assurance, Process Improvement, Resource Planning, Performance Management
Preferred skills
CRO experience, Rare disease/Oncology trial experience, Strategic planning, Audit defense
Technologies
SAS, R
Responsibilities
Manage and mentor a team of Statistical Programmers; oversee project activity including quality, budget, and timelines; develop best practices and controlled documents; support regulatory submission integration; represent the department in audits and conferences; drive operational excellence and efficiency initiatives.
Seniority
Manager, hands-on leadership
