When our values align, there's no limit to what we can achieve.
The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.
Key Accountabilities:
Operational Execution
1. Provide broad statistical support, including trial design, protocol and CRF development on specific studies.
2. Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
3. Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols.
4. Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans.
5. Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review.
Business Development
6. Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings.
General Activities
7. Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis.
8. Understand, apply and provide training in extremely advanced and sometimes novel statistical methods.
9. Contribute to the development and delivery of internal and external statistical training seminars and courses.
10. Review position papers based on current good statistical practice.
11. Interact with clients and regulatory authorities.
12. Review publications and clinical study reports
13. Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
14. Additional responsibilities as defined by supervisor/manager.
Skills:
15. Good analytical skills.
16. Good project management skills.
17. Professional attitude.
18. Attention to detail.
19. Thorough understanding of statistical issues in clinical trials.
20. Ability to clearly describe advanced statistical techniques and interpret results.
21. Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines).
22. Prior experience with SAS programming required.
23. Ability to work independently.
24. Good mentoring/leadership skills.
25. Good business awareness/ business development.
Knowledge and Experience:
26. The knowledge of pharmacokinetic data is an advantage.
27. Competent in written and oral English
Education:
28. PhD in Statistics or related discipline, MS in Statistics or related discipline.