Sr. Statistical Programmer

Position Summary

Our client is seeking a highly skilled Senior Statistical Programmer to join their team on a long-term contract basis. This is a hands-on role ideal for someone with experience in a small sponsor or biotech environment, where close collaboration with cross-functional teams is key. This position requires strong experience with Phase III studies, BLA submissions, and SAS Macro development.

The role will also focus on quality control (QC) of vendor-delivered programming outputs, with some in-house programming to validate and compare analysis datasets.

Key Responsibilities

• Perform QC and validation of vendor-delivered analysis datasets, tables, listings, and figures (TLFs).
• Develop and maintaining SAS macros to support analysis datasets (SDTM / ADaM), TFLs, and regulatory (BLA) submissions
• Conduct limited in-house programming, primarily ADaM dataset development, to ensure vendor quality and compliance.
• Collaborate closely with internal Biostatistics, Data Management, and Clinical teams to support ongoing clinical studies.
• Ensure adherence to CDISC standards (ADaM and SDTM) and company programming best practices.
• Participate in cross-functional discussions to resolve data or analysis-related issues and ensure timely delivery of submission-ready outputs.

Qualifications