Job Description

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

The Senior Statistical Programmer will provide statistical programming expertise and strategic support to global clinical studies. In this role, you will work closely with cross-functional stakeholders to review and interpret clinical trial data, support statistical analyses, and ensure the quality and integrity of statistical and data management deliverables produced both internally and by external partners.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is advancing innovative therapies in areas of significant unmet medical need.

Key Responsibilities

• Develop, validate, and maintain SAS programs for clinical trial reporting and analysis.
• Generate and review SDTM and ADaM datasets in accordance 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 informed decision making.
• Evaluate protocol deviations and contribute to assessments of their potential impact on study outcomes.
• Review statistical analyses, datasets, and deliverables generated by external service providers.
• Collaborate with Biostatistics, Clinical Operations, and Data Management teams to ensure high quality study execution.
• Contribute to data review activities and support the development of analysis specifications and programming documentation.
• Support regulatory submissions and ensure statistical deliverables are inspection-ready.
• Drive continuous improvement of programming standards, processes, and automation initiatives.

Qualifications

• 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.
• Strong SAS programming skills.
• Experience with CDISC standards, including SDTM and ADaM.
• Experience producing Tables, Listings, and Figures (TLFs).
• Solid understanding of clinical trial methodology, ICH-GCP, and regulatory requirements.
• Ability to review and interpret clinical data and statistical outputs.
• Experience working with external vendors or CRO partners is highly desirable.
• Strong communication skills and the ability to collaborate effectively within global cross-functional teams.
• Knowledge of Data Management processes and R programming is considered an advantage.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.