Job Description
You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.
In this role, you will:
1. Act as a communication line for project teams, clients, vendors and internal team on statistical questions
2. Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
3. Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
4. Review statistical deliverables such as tables, figures, listings and analysis datasets
5. Conduct departmental induction course and project-specific training for statisticians and SAS programmers
6. Prepare for and attend internal and external study audits pertinent to Statistics
7. Participate in preparation of internal/external audits follow up
8. Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics
9. Liaise with DM on statistical questions related to data issues
10. Participate in bid defense and in kick-off meetings
11. Lead teams of SAS programmers and/or statisticians on the project level
Qualifications
12. MSc in Statistics or equivalent
13. Full working proficiency in English
14. Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
15. Expert knowledge and understanding of the SAS programming
16. Expert knowledge and understanding of CDISC ADaM standard
17. Expert knowledge and understanding of pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis
18. Expert knowledge and understanding of Phoenix WinNonlin and NLME
19. Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
20. Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
21. Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
22. Strong presentation and communication skills