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Biostatistician
2 months ago
[Job Responsibilities]
Ø Responsible for statistical design, sample size estimation, development of statistical analysis plans (SAP), including statistical methods, key statistical programming programs, definition of derived variables, data processing rules, and establishment of analytical models
Ø Review the research protocol and case report form (CRF/eCRF)
Ø Responsible for the randomization process, including blind base preparation, drug blinding, etc. Assist the project team in completing quality control of the randomization process.
Assist data management personnel in providing suggestions on database design and be responsible for reviewing case reports (CRF), critical data, and data quality
Review and be responsible for the quality of statistical programming charts, clinical research reports, and other statistical results
[Technology/Skills]
Master's degree or above, majoring in statistics, mathematics, or related fields
Good communication skills and the ability to establish good relationships
Good teamwork skills and efficient cross departmental work
Proficient in using statistical software such as SAS, R, etc
Understand compounds, disease domains, and regulatory guidelines, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and relevant experience/knowledge of CDISC
