Reporting to the Sr Manager, Biostatistics and Stat Programming, the ideal candidate will have experience conducting statistical analysis for clinical trials, writing Statistical Analysis Plans (SAP), writing support for protocols and clinical study reports, and knowledge of regulations and ICH standards related to statistics.
The key responsibilities are:
· Management of CRO responsible for the statistical analysis of the Prulifloxacin NDA.
· Oversight of Tables, Listings, Figures (TLFs) development for ISE/ISS analysis.
· Writing statistical related sections of the ISE/ISS.
· Represent statistics and stat programming in all Prulifloxacin team meetings.
· Lead effort in data exploration of the Prulifloxacin clinical trial data.
To find out more about this position, and to apply, visit Gobiojobs.com
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