ㆍOrganize data from medical research and analyze it to draw conclusions or make predictions. ㆍDesign clinical research and develop protocols of clinical trials in collaboration with other medical team members. |
ㆍCreate and review documentation related to clinical research. ㆍStatistical analysis: Proceed statistical analysis of clinical study results for licensure. ㆍSample size calculation: Calculate sample size for licensing-related clinical studies. ㆍClinical documentation: Describe the statistical section of a license-related clinical study plan/results document. ㆍClinical documentation review and improvement: Participate in the overall review and improvement of internal clinical documentation.
[Qualifications]
ㆍMaster’s Degree or more in a relevant field of Statistics/Biostatistics. ㆍMinimum 2 years of experience in relevant industries. ㆍProficiency in statistical analysis software (including experience with R software) ㆍFamiliarity with and compliance with regulatory institutions` regulations. ㆍAbility to search and review literature. ㆍExperience in medical device clinical trials and phase 1-3 clinical trials. ㆍClinical data management experience.
[Preferred Experience]
ㆍProficiency in SAS, SPSS, and other analytical programs
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