Senior Statistical Programmer

Role Summary

We are seeking a highly experienced Senior / Lead Statistical Programmer for a part-time engagement to support clinical trial programming activities within a CRO environment. This role is ideal for seasoned professionals who can provide deep technical expertise, quality oversight, and delivery leadership on a flexible schedule.

The role focuses on advanced SAS programming, CDISC compliance, regulatory-ready deliverables, and close collaboration with biostatistics and cross-functional teams.

Key Responsibilities

• Lead and execute statistical programming activities for one or more clinical studies on a part-time basis
• Develop, review, and optimize SAS programs for clinical trial data analysis
• Oversee creation and validation of SDTM and ADaM datasets in compliance with CDISC standards
• Generate and review Tables, Listings, and Figures (TLFs) for interim, final, and regulatory submissions
• Support interim analyses, final analyses, Clinical Study Reports (CSRs), and regulatory deliverables
• Perform and oversee QC, independent validation, and peer review of programming outputs
• Provide technical guidance and mentoring to junior programmers as needed
• Collaborate closely with biostatisticians to ensure accurate implementation of statistical analysis plans
• Ensure adherence to SOPs, GxP guidelines, and regulatory requirements
• Maintain complete programming documentation, traceability, and version control
• Support audits, inspections, and sponsor queries related to statistical programming

Required Skills & Experience

• 10–15 years of hands-on experience in statistical programming within a CRO or regulated clinical research environment
• Strong expertise in SAS (Base SAS, Macros;
  SAS/STAT preferred)
• Advanced working knowledge of CDISC standards (SDTM, ADaM)
• Proven experience supporting Phase I–IV clinical trials
• Strong understanding of the clinical trial lifecycle and regulatory expectations
• Experience supporting FDA, EMA, or other global regulatory submissions
• Ability to work independently with minimal supervision in a part-time setup
• Strong analytical, problem-solving, and communication skills