Works independently with minimal supervision and manage high volume work flow. Uses independent judgment to execute duties and responsibilities. Oversees work of team members. Developing/Updating statistical SOPs (as appropriate) for the BA/BE/clinical studies. Literature search for statistical section's related to the study and resolve statistical queries of the item. Responsible for statistical aspects of the trials: experimental design, selection of appropriate statistical methodology, sample size estimation, protocol review, generation of randomization number, statistical analysis of data, and report preparation. Preparation statistical section of protocol and Statistical Analysis Plan (SAP) Review/ Perform Pharmacokinetic analysis for Biostudies using Phoenix WinNonlin Perform statistical analysis & generate statistical outputs for clinical trial using SAS Statistical deficiency handling. Reporting statistical tables and related computer outputs (Ex: SAS Export files) Perform the activities for eCTD submission as per CDISC standards. Clinical Data Management (CDM) responsibility: Review of CRF, Edit check specification, DMP and all documents related to CDM for clinical trial Assist in CDM related activities like database design, data entry, data listing review, etc. Works closely with the study team to reach consensus on timelines for deliverables Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance | 
