Senior Biostatistician - Pharma

- Preparation and Review of Statistical Analysis Plan (SAP) and MOCK Shells

- Provide statistical inputs for the clinical trial protocol

- Determination of sample size for Phase II, III and IV clinical trials

- Generation of randomization schedule

- SAS Programming specifications for analysis datasets, Table, Listing and Figures (Efficacy and safety tables)

- QC of Table, Listing and Figures (Efficacy and safety tables)

- Review of SAS annotated Case Report Form as per the CDISC standards and other study documents to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis

- Statistical analysis of clinical trial data

- Coordination with statistical programmer on assigned projects to ensure timely completion of high quality work

- Review of Clinical study report from statistical aspects ensuring that results are captured in consistent with the analysis described in the SAP

- Preparation and Review of SAS and Biostatistics related departmental SOPs