Senior Statistical Programmer - Clinical Data Management
First seen by Alion on Sep 30, 2026.
Job Description :
- Lead clinical trial SAS programming (Phase II - IV).
- Create and validate CDISC SDTM, ADaM, TLFs, and regulatory deliverables (Define.xml, eCRT).
- Manage project timelines, mentor junior staff, and support multi-disciplinary clinical study teams.
Key Responsibilities :
- Develop and validate SDTM and ADaM datasets to ensure compliance with CDISC standards and project-specific specifications for clinical study reporting.
- Program complex tables, listings, and figures (TLFs) using SAS to support clinical study reports and integrated summaries of safety and efficacy.
- Perform rigorous quality control and validation of programming deliverables to ensure accuracy, consistency, and adherence to regulatory guidelines.
- Collaborate with cross-functional teams to resolve data discrepancies and clarify programming requirements throughout the study lifecycle.
- Provide technical guidance and mentorship to junior team members to ensure project timelines and quality standards are consistently met.
- Maintain comprehensive documentation for all programming activities to ensure audit readiness and compliance with internal standard operating procedures.
Requirements :
- 5 - 9 years clinical/CRO experience with 5+ years in SAS.
- Expertise in end-to-end SDTMs/ADaMs, TLFs, and 2+ therapeutic areas (including oncology).
- Strong background in statistics or CS.
Total Experience: 5 - 9 years
Skills
SAS, SDTM, Clinical Data Management, Statistical Modeling, ADAMS, CDISC SAS, Reporting Tools, Statistical Analyst