Statistician
Statistician
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Job Description
Job Summary
1. Work with clinical research scientist to develop clinical protocols. This includes:
a. Hypothesis forming and testing principle determination
b. Sample size estimation and justification taking into consideration of potential errors
c. Authorizing the statistical analysis section of the protocol
2. Review CRO proposals in the scope and appropriateness of the proposals and budget
3. Prepare a statistical analysis plans for phase 1 or phase 2 proof of concept clinical trials
4. Review the statistical analysis plan prepared by CROs and confirm the completeness of the analysis plan
5. Review the tables and listings provided by CROs and the statistics report in the clinical study report
6. If candidate has relevant experience prepare the statistical sections of the regulatory documents
Qualifications
1. Masters degree inStatistics with at least 5 years of experience in FDA regulated projects or PhDdegree Statistics or related fields with 3 years of clinical research related experiences.
Employment Type
Full-Time
