Senior Statistical Programmer - Clinical Data Management

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