We are seeking an experienced and proactive Principal Biostatisticianto join our FSP team, supporting a global pharmaceutical client. This is apermanent, home-basedposition offering the opportunity to work onlate-phase global oncology trials, with a focus onhematologyandregulatory submissions.
Key Responsibilities
1. Serve as thelead statisticianon globallate-phase registration trials, particularly in oncology (hematology preferred).
2. Independently contribute tostudy design,statistical analysis plans (SAPs), andregulatory submission strategies.
3. Participate instudy team meetings, providing statistical guidance and collaborating with cross-functional teams.
4. Addresshealth authority questionsand support responses with appropriate statistical analyses and documentation.
5. Performhands-on statistical programmingto derive outputs and summary statistics usingADaMandSDTMdatasets.
6. Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards
Required Qualifications
7. Advanced degree (Master’s or PhD) inBiostatistics,Statistics, or a related field.
8. 5+ yearsof experience in clinical trials, with a strong focus ononcology(hematology and late-phase preferred).
9. Proven experience working onregistrational studiesandregulatory submissions.
10. Strong knowledge ofCDISC standards, particularlyADaMandSDTM.
11. Proficiency inSASprogramming and ability to perform hands-on statistical analyses.
12. Excellent communication skills and ability to work independently in a global, cross-functional environment.
Preferred Experience
13. Prior involvement inFDA/EMA submissions.
14. Experience addressingregulatory agency queries.
15. Familiarity withreal-world evidenceandobservational studiesis a plus.
Why Join Us?
16. Work onhigh-impact global studieswith a focus on improving cancer treatment outcomes.
17. Be part of acollaborative and innovativeteam environment.
18. Enjoy theflexibility of remote workwith a permanent contract.
19. Gain exposure toregulatory strategyandcutting-edge oncology research.
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