The Principal Statistician (Pharmacokinetics) at PSI CRO will lead statistical activities for global clinical trials, serving as a biostatistics project lead and collaborating with international teams of statisticians, programmers, and data managers. This role ensures robust statistical support and high-quality deliverables throughout the clinical trial lifecycle.
What You'll Do
- Act as a communication line for project teams, clients, vendors and internal team on statistical questions
- Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
- Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
- Review statistical deliverables such as tables, figures, listings and analysis datasets
- Conduct departmental induction course and project-specific training for statisticians and SAS programmers
- Prepare for and attend internal and external study audits pertinent to Statistics
- Participate in preparation of internal/external audits follow up
- Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics
- Liaise with DM on statistical questions related to data issues
- Participate in bid defense and in kick-off meetings
- Lead teams of SAS programmers and/or statisticians on the project level
Technical Stack
- CDISC ADaM
