Recruiter at Talent Management Solutions
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Biostatistician (8-14 yrs)
This is middle to senior middle level position requiring relevant experience in clinical trials from phase I to IV and BA BE studies. Who can analyze and interpret the data generated through earlier studies and can design the studies (including adaptive protocol designs for seamless product development) for submission to global regulatory authorities including US FDA. The position requires comprehensive evaluation of the generated data and consolidated compilation of data with statistical justification for submission.
Other routine tasks involved are mentioned below :
1. Clinical trial sample size estimation for different designs of clinical trials
2. Statistical analysis of clinical trials
3. Efficient in PK analysis
4. Efficient in statistical analysis of PK/ PD and other efficacy parameters
5. Interim and trend analysis
6. SOP preparation/ review
7. Execute analysis in SAS as specified in the protocol or the Statistical
Analysis Plan (SAP) under the guidance of the statistician.
8. Perform validation of the SAS programs, analysis datasets, tables, listing and figures.
9. Review of CRF and its annotations, database data specifications, statistical analysis plan (SAP) and TLF mock shells.