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Job description

Roles and Responsibilities:

To efficiently perform below mentioned biostatistics activities toward development / validation of deliverables: - Estimate sample size for the trial, - Provide statistical inputs to protocol, - Generate randomization list, - Drafting / validation of statistical analysis plan (SAP), - Generation of protocol deviation list, - Drafting / Validation of statistical analysis report (SAR).
Provide statistical input to clinical study report (CSR) and actively participate in review and finalization of CSR
Review clinical study report, perform blind data review and data inspection
Provide statistical outputs required for Data and Safety Monitoring Board(DSMB) meetings
Participate in project meetings
Create / validate SAS programs for generation of tables, figures, listings and CDSIC deliverables
Perform any other assigned activities towards Biostatistics or programming in SAS for analyzing data.
Ensure compliance to relevant SOPs
Identify issues and implement corrective and preventive action.
Analyze issues & identify the corresponding system/process changes/ training needs
Be prepared for any audits and inspections
Enhance process performance for Biostatistics activities

Interested candidates please share your resume on [contact via apply]

Bio-Statistician

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