About the role
Contract Statistician
We are seeking an experienced Contract Statistician to support clinical development from early to late-stage development. The successful candidate will need to have extensive experience in the statistical design, analysis, and reporting of clinical trials across Phases I–III, with a strong understanding of regulatory requirements and submission standards.
Key Requirements:
- Proven experience in statistical design and analysis of Phase I–III clinical trials.
- Expertise in developing statistical analysis plans (SAPs), protocol input, sample size calculations, and study design.
- Oncology Experience
- PK/PD Knowledge
- Bayesian Statistics
- Hands-on experience supporting regulatory submissions (e.g. FDA, EMA), including preparation and review of submission-ready statistical documentation.
- Proficiency in SAS
- Strong knowledge of ICH guidelines, CDISC standards (SDTM/ADaM), and Good Clinical Practice (GCP).
- Excellent communication skills and the ability to work effectively within multidisciplinary project teams.
This is a contract opportunity for a highly motivated statistician who can provide expert statistical leadership and deliver high-quality outputs within project timelines.
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