Overview
In this role you will apply advanced statistical programming to support clinical trials, acting as a technical expert and project lead when needed. You will collaborate with sponsors and cross-functional teams to deliver high-quality analyses and submissions while guiding timelines, budgets, and resource planning. You’ll mentor staff, expand regulatory knowledge, and ensure compliance with ICH-GCP, CDISC, and 21 CFR Part 11. This is a remote-friendly position across the UK, Poland, Hungary, and Serbia with a focus on a single sponsor.
Pay / Benefits
- remote work
- flexible working hours
- work-life balance
- professional growth and development opportunities
Responsibilities
- Lead statistical programming efforts on projects and, when needed, fill the Statistical Programming Lead role
- Negotiate and manage timelines, monitor budgets and resource needs
- Coordinate a programming team to complete studies within time and budget
- Review SAS/SQL code, SAS datasets specifications, and SOPs for QC and regulatory readiness
- Develop and review SDTM/ADaM datasets, tables, figures, and listings
- Prepare dataset specifications and submission documents
- Interact with sponsors and internal stakeholders on programming issues
- Provide troubleshooting and problem-solving support to project teams
- Ensure QC and adherence to quality standards and regulatory requirements
- Train and mentor staff on R and programming processes
Key requirements
- Proficiency in R
- Strong analytical skills
- Experience leading a global team
- Extensive knowledge of programming and reporting processes
- Knowledge of SOPs/Guidelines, ICH-GCP, and 21 CFR Part 11
- Ability to learn new systems and work in evolving technical environments
- Strong project management and organizational skills
- Attention to detail and time management
- Customer focus and problem-solving abilities
- Good presentation and business development skills
- strong communication
- collaboration
- mentorship
- R
- SDTM
- ADaM
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