Description
Sr. Statistician* Support clinical trial design and protocol concept sheet development
* Develop protocols especially for statistical section
* Participate study related activities and provide statistical support such as safety review, interim analyses for Phase II and III oncology studies, etc.
* Develop statistical analysis plan (SAP), create TLG template and derived analysis datasets specification, perform QC of TLG.
* Contribute to CRF development and review edit check specification
* Develop Data Monitoring Committee Charter and create mocked TLG for interim review
* Review Independent Radiology Review Committee Charter and data transfer plan
* Review CSR and submission documents to support submission
For qualification:
Qualifications:
* At least 4 years clinical trial experience (oncology experience preferred) with Ph.D. in statistics
* Familiar with oncology trial design and survival analysis
Good experience in exploratory analysis
Min 3 years Pharma exp
* Good communication skill
* Excellent programming skill in SAS
* Familiar with statistical software such as East, nQuery, Splus and others.
* Team work attitude
* Able to handle multiple projects concurrently .
To find out more about Real please visit www.realstaffing.com