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Regulatory Submissions
Accountabilities:
- Serve as a senior statistical expert supporting clinical studies from protocol design through clinical study report completion.
- Provide statistical leadership on study design, analysis strategies, and interpretation of clinical trial results.
- Develop, review, and oversee Statistical Analysis Plans, including specifications and mock-up tables, listings, and figures.
Requirements:
- Graduate degree in Biostatistics, Statistics, or a related quantitative discipline with extensive experience in clinical trials.
- Strong understanding of statistical methodology, clinical trial design, and regulatory guidelines such as ICH standards.
- Proficiency in R programming and experience applying statistical techniques in clinical research environments.
Benefits:
- Fully remote working opportunity from Europe with flexible work arrangements.
- Opportunity to contribute to meaningful clinical research programs that support development of new therapies.
- Collaboration with international teams and career development opportunities through training and mentorship.
Partner Company
This company provides clinical research services and statistical expertise for early-phase drug development. It fosters an inclusive, collaborative culture with opportunities for career growth and mentorship.