Senior Statistical Programmer (R Programming) - UK, Poland, Serbia, Hungary - FSP
United Kingdom-Sheffield-Remote
R
GBP 60K-90K (estimate) Senior-level Full Time
Tasks
- Coordinate global program creation
- Create and maintain tracking spreadsheets
- Create tables figures and data listings
- Develop ADaM
- Develop SDTM
- Ensure quality control per SOPs and ICH GCP
- Generate dataset specifications
- Interact with sponsors and internal stakeholders
- Lead statistical programming projects
- Maintain submission documentation
- Negotiate statistical programming timelines
- Produce and QC derived datasets
- Provide consultancy for statistical programming tasks
- Provide regulatory compliance and audit support
- Provide training and mentorship
- Review database setup specifications
- Review mock shells
- Review statistical analysis plans
- Support process and quality improvement initiatives
Perks/Benefits
- Flexible working hours
- Inclusive work environment
- Professional growth and development
- Work-life balance
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | CDISC | CFR Part 11 | Clinical trials | Data Listings | Dataset specification | Electronic submission | ICH GCP | Mock Shell | Part 11 | Project Management | QC | Quality Control | R | S&OP | SDTM | Statistical Analysis | Statistical Analysis Plan
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD | University Degree
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