Sr. Statistical Programmer with SDTM / Metadata management specialization

Role Summary

Programming Responsibilities

• Develop SAS or other software code for summary tables, listings, graphs, and derived datasets.
• Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project teams.
• Develop complex dataset and output specifications to statistical and sponsor requirements.
• Maintain complete programming, testing, verification, and quality-control documentation.
• Manage timelines and priorities across multiple projects and complete programming activities within agreed timeframes.
• Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.
• Direct programming activities, monitor deliverable progress, and provide feedback to reduce inefficiencies.
• Participate in sponsor, kickoff, and bid-defense meetings when required.
• Mentor programming personnel through training, reviews, feedback, and guidance.
• Minimal travel may be required.

Qualifications

• Undergraduate degree, preferably in a scientific or statistical discipline, or equivalent education and demonstrated programming experience.
• Extensive SAS or other required software programming experience.
• Clinical trial environment experience is preferred.
• Excellent written and verbal communication skills are required.
• Ability to read, write, speak, and understand English is required.

Technical and Domain Skills

• Statistical programming for analysis datasets, tables, listings, and figures.
• SAS programming, validation, and database design review.
• Clinical trial and sponsor programming requirements.
• Applicable SOPs, work instructions, and regulatory guidance such as ICH.

Development and Rewards

• Career development, progression, line-management support, technical and therapeutic-area training, peer recognition, and total rewards are described.