Senior Statistical Programmer

About the role

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. The Senior Statistical Programmer provides statistical programming expertise and strategic support to global clinical studies, working closely with cross-functional stakeholders to review and interpret clinical trial data and ensure the quality and integrity of statistical and data management deliverables, both internal and from external partners. The role sits within the SRS/FSP team and is dedicated to one sponsor, a global pharmaceutical or biotechnology company.

Key responsibilities

• Develop, validate and maintain SAS programs for clinical trial reporting and analysis.
• Generate and review SDTM and ADaM datasets in line with CDISC standards.
• Produce and validate Tables, Listings and Figures (TLFs) for study reports and regulatory submissions.
• Review, assess and interpret clinical study data to support study teams and decision making.
• Evaluate protocol deviations and their potential impact on study outcomes.
• Review statistical analyses, datasets and deliverables from external service providers.
• Collaborate with Biostatistics, Clinical Operations and Data Management teams, and help develop analysis specifications and programming documentation.
• Support regulatory submissions so that statistical deliverables are inspection-ready.
• Drive continuous improvement of programming standards, processes and automation.

Required profile

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences or a related field.
• Experience in statistical programming within the pharmaceutical, biotechnology or CRO industry.
• Solid understanding of clinical trial methodology, ICH-GCP and regulatory requirements.
• Ability to review and interpret clinical data and statistical outputs.
• Strong communication skills and ability to work in global cross-functional teams; experience with external vendors or CRO partners is highly desirable.

Required skills

• Strong SAS programming skills.
• Experience with CDISC standards (SDTM and ADaM).
• Experience producing Tables, Listings and Figures (TLFs).
• Knowledge of Data Management processes and R programming is an advantage.