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 (FSP) solutions.
The Programming Lead is responsible for providing oversight and ensuring deliverables align with the client's requirements.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company that is an industry leader.
Please keep in mind that this is a Contractor/Freelance position of approx. 10 h per month.
Key Responsibilities
Provide oversight of outsourced statistical programming deliverables, including SDTM, ADaM datasets and Tables, Listings, and Figures (TFLs), ensuring compliance with internal standards and regulatory requirements.
Perform technical review and quality oversight of vendor programming outputs, including datasets, derivations, specifications, and analysis programs.
Ensure timely delivery of study milestones, including interim analysis outputs and final study report deliverables.
Coordinate with statisticians, internal teams, and external programmers to clarify specifications, resolve issues, and ensure alignment across programming activities.
Support data review and transfer activities within EU-restricted systems, including entimICE and LSAF environments.
Qualifications
Extensive experience in clinical statistical programming in the pharmaceutical or biotech industry.
Strong expertise in CDISC standards (SDTM and ADaM) and generation/review of TFLs.
Proven experience in programming lead or vendor oversight roles managing outsourced programming deliverables.
Advanced programming skills with the ability to review complex programs and derivations.
EU-based with the ability to review study data within EU-restricted environments due to patient data transfer limitations.
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.
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