Contract Statistical Programmer – Cutting-Edge Gene Therapy Biotech
Remote, UK
Outside IR35
Are you an experienced Statistical Programmer looking for an opportunity to contribute to ground-breaking gene therapy research? We are working with a pioneering biotechnology company that is revolutionizing genetic medicine through advanced AAV vector platforms. This clinical-stage, international biotech is on a mission to develop life-changing therapies for patients with no current treatment options.
We are seeking a Principal SAS Programmer to support a cutting-edge gene therapy clinical trial program in ophthalmology. This is a key role in driving the success of clinical trials by managing complex datasets, ensuring compliance with CDISC standards, and delivering high-quality programming outputs for regulatory submissions.
The Role
As a Principal SAS Programmer, you will:
✅ Provide expert-level SAS programming support for gene therapy ophthalmology programs.
✅ Develop, maintain, and validate SAS programs for clinical trial data analysis and reporting.
✅ Ensure compliance with CDISC SDTM and ADaM standards, supporting regulatory submissions.
✅ Collaborate cross-functionally with biostatistics, clinical operations, and regulatory affairs teams.
✅ Lead process-driven initiatives to optimize programming workflows and improve efficiency.
✅ Develop validation checks, resolve data discrepancies, and ensure data integrity throughout trials.
✅ Mentor and provide technical leadership to junior programmers.
Key Requirements
✔️ Experience: 8-10 years in SAS programming within clinical trials, with a strong background in ophthalmology.
✔️ Technical Skills: Expertise in SAS (BASE, STAT, MACROS, SQL), CDISC SDTM/ADaM standards, and regulatory submission preparation.
✔️ Clinical Knowledge: Deep understanding of clinical trial design, data management, and reporting processes.
✔️ Leadership & Problem-Solving: Ability to manage complex datasets, lead process improvements, and mentor junior staff.
✔️ Regulatory Knowledge: Experience with FDA/EMA submissions and familiarity with eCTD, NDA, or BLA processes.
Preferred Skills
➕ Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
➕ Knowledge of R programming or other statistical tools.
Why Join?
Work with a globally recognized biotech at the forefront of gene therapy.
Play a pivotal role in life-changing clinical research.
Be part of a collaborative and innovative team driving advancements in genetic medicine.
If you’re a highly skilled SAS Programmer eager to make an impact in ground-breaking gene therapy research, we want to hear from you!
Apply today or reach out to our recruitment team for more details.