Senior Statistical Programmer

Role Description

We are seeking a Senior Statistical Programmer to join our team in a remote capacity. As a Senior Statistical Programmer, you will provide technical expertise to support clinical trial analysis and reporting activities while serving as a key contributor to the delivery of high-quality statistical programming solutions. This role may act as a Statistical Programming Coordinator on projects, partnering closely with sponsors, Data Operations Leads, biostatisticians, and cross-functional teams to ensure timely, compliant, and effective study delivery.

You will support a broad range of programming activities related to clinical study data, including:

• Derived dataset programming
• Quality control
• Mapping specification development
• Import and export programming activities
• Adherence to industry data standards

This position offers the opportunity to influence study outcomes, provide technical leadership, contribute to process improvements, and expand expertise across statistical programming and clinical development. You’ll join a fast-paced, growth-oriented environment focused on delivering quality, efficiency, and innovation in clinical research.

With access to global teams, challenging projects, and continuous learning opportunities, the Senior Statistical Programmer can further develop technical, leadership, and project delivery expertise while helping bring new therapies to patients.

Qualifications

• Degree in relevant discipline or equivalent work experience.
• Relevant clinical trial industry experience.
• Proficiency in SAS and strong knowledge of programming and reporting processes.
• Knowledge of ICH-GCP, regulatory requirements, System Life Cycle methodologies, and industry technical standards including 21 CFR Part 11.
• Experience supporting statistical programming activities related to clinical study analysis and reporting.
• Excellent communication skills with competency in written and oral English.
• Strong organizational skills, ability to manage competing priorities, and flexibility in a dynamic environment.
• Demonstrated commitment to quality management, teamwork, and problem solving.

Requirements

• Demonstrated experience serving as an SDTM Lead on clinical research studies.
• Experience in the development of SDTM Trial Design domains.
• Proven ability to program and deliver complex SDTM datasets.
• Experience coordinating study and project start-up activities.
• Proficiency in troubleshooting and debugging macros of moderate complexity.
• Strong understanding of efficacy endpoints and efficacy assessment methodologies, including RECIST and IMWG applications.
• Experience reviewing Protocols and Statistical Analysis Plans (SAPs) and providing feedback related to SDTM mapping strategies and implementation.
• Solid foundational SAS programming skills.

Benefits

• Access to global teams.
• Challenging projects.
• Continuous learning opportunities.