Biometrics & Data Science
Contract Senior Biostatistician
Support the statistical work behind a Phase 2b readout in ulcerative colitis. A nine-month remote contract with clear deliverables and direct access to the study team.
A typical mandate
The company develops an oral therapy for inflammatory bowel disease, with a Phase 2b study in ulcerative colitis approaching database lock. The in-house biostatistics team is lean. It needs senior support through the readout and end-of-phase 2 preparation.
What the role owns
- Finalize the statistical analysis plan and table shells ahead of database lock
- Review and validate TLFs and ADaM datasets produced by the CRO
- Run supportive and exploratory analyses in SAS or R
- Contribute to the topline report and end-of-phase 2 briefing package
- Answer analysis questions from clinical and regulatory colleagues
What great candidates bring
- MS or PhD in biostatistics or statistics
- 7+ years in industry clinical trials, including Phase 2 or Phase 3 readouts
- Hands-on SAS programming; R is a plus
- Working knowledge of CDISC ADaM and the ICH E9(R1) estimand framework
- Inflammatory bowel disease or immunology experience preferred
Why it matters
- Nine-month contract with a defined scope
- Fully remote, with flexible hours
- Direct partnership with the head of biostatistics
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