R0000045029 Senior Statistical Programmer (R Programming) - UK, Poland, Serbia, Hungary - FSP
United Kingdom-Harrow-Remote
R
GBP 60K-90K (estimate) Senior-level Full Time
Tasks
- Coordinate and lead statistical programming team delivery
- Coordinate project start up and global program creation
- Develop and review dataset specifications and submission documentation
- Ensure compliance with SOPs guidelines and ICH GCP
- Lead process and quality improvement initiatives
- Lead statistical programming activities for clinical trials
- Maintain study documentation for traceability and regulatory compliance
- Monitor quality timelines resources and productivity
- Negotiate statistical programming timelines
- Participate in internal and external audits and inspections
- Provide consultancy to sponsors on statistical programming tasks
- Provide technical expertise for clinical trial conduct
- Provide training and mentorship for staff and teams
- QC derived datasets tables figures and data listings
- Review statistical analysis plans and mock shells
Perks/Benefits
- Collaborative inclusive work environment
- Flexible working hours
- Professional growth and development
- Work-life balance
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trial | Data Listing | Data Set | Data Set Specification | Figures | ICH GCP | Part 11 | Programming | QC | Quality Control | R | S&OP | SDTM | Tables
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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