Radiant Systems Inc
Senior Statistical Programmer
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Senior Statistical Programmer
Senior Statistical Programmer – Remote | Harlow, UK (24 Month Contract)
About the Role
The Clinical Programming (Contractor) provides comprehensive programming support within clinical trials, overseeing the accurate and timely execution of programming components. This role involves managing end-to-end projects involving global tasks or cross-functional teams, delivering inputs to study design and analysis, and reporting clinical trial results—including programming frameworks and mocked tables (TL/G datasets). Additionally, support is provided for publication-worthy statistical analyses of marketed drugs.
Key focus areas include:
- Study/product/per protocol-level programming and data management
- CDISC submission frameworks (eCRF-to-submission pipelines)
- Development and maintenance of SAS-based programming workflows
Key Responsibilities
-
Development & Quality Assurance
- Draft SAS programs, ADaM specifications, and databases, ensuring regulatory compliance with FDA/EMA/ICH/CDISC standards and internal SOPs.
- Deliver timely, high-quality programming deliverables (datasets, TLFs) within project timelines.
- Collaborate with Data Management to streamline database designs for analysis integrity.
-
Regulatory & Submission Support
- Develop, debug, and enhance SAS programs for quality control of safety/efficacy datasets and TLFs.
- Generate CDISC-based e-submissions (including SDTM/ADaM datasets and TLGs).
- Perform mock or pre-submission inspections and fine-tune TL/FG standards to support Bioresearch Monitoring compliance.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
- Global Standards & Process Improvement
- Standardise gSD (global study data) deliverables (e.g., TLGs, datasets) within therapeutic areas.
- Identify process inefficiencies and propose improvements with cross-functional teams (Stat, Data, Medical).
- Proactively address data integrity issues via transparent communication with stakeholder teams.
Requirements
Education
- Bachelor’s or Master’s degree in Science/Statistics/Information Technology (or relevant equivalency/certificate).
- Regulatory experience encouraged (pharmaceutical, medical device, or clinical research background).
Experience
- Minimum 5 years post-degree (Bachelors) or +4 years (Masters) in pharmaceutical or clinical research as a programmer.
- Proficiency across entire drug development lifecycle (proto/mid-to-late phase, submissions, publications).
- Hands-on experience with:
- CDISC frameworks (SDTM, ADaM) and submission interfaces (e.g. Pinnacle²¹, VSX).
- SAS, including macro programming, data steps, and statistical reporting.
- XML/SOAP configurations for CDISC submissions.
- Microsoft Office (Excel Power Query), database design, and version control (e.g. SVN, Git).
Get help with your application
Your very own career expert that helps elevate your application to the next level.
- Prior mock inspection support or BIMO participation (desirable).
Technical Skills
SAS & Statistical Proficiency
- Expertise in writing custom SAS-code (moral adaptive programming for edge cases).
- mastery of efficacy analysis methods: ANCOVA, repeated measures, survival analytics.
CDISC & Submission
- Deep knowledge of SDTM/raw structures, ADaM programming (e.g., parameterisation, dataset exposure covariates).
- Proven capability in designing GL assists/anchors for regulatory queries.
- Familiarity with VSX or equivalent as well as ** STUDY DATA USAGE INTERFAGES**.
Regulatory Environment
- Familiarity with ICH GCP, FDA/BEMA/IR policies, EMA guidelines for data input/output compliance.
- Ability to interpret CDISC datasets during audits/inspections.
Soft Skills
- Independent problem-solving with responsibility for critical-path SPOC deliverables.
- Strong completely/communication skills with St, DM/BIU, and QA, written in team status updates.
- Structured prioritisation under tight deadlines.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills
Location