<ul><li>The job requires to review pilot and pivotal study protocols with respective to STAT / PK section to ensure regulatory compliance, to review pivotal study statistical reports with respective to STAT.</li><li>SAS output and CDISC data sets as per regulatory compliance. in-vitro data analysis &amp; providing feedback to formulation / ADL team. PK Stat analysis of pilot / pivotal BE study, exploratory PK analysis and interpretation of pilot study result of different dosage forms, shelf life and stability data analysis and other statistical activities as per regulatory requirement.</li><li>To provide statistical inputs in regulatory query response and sample size calculation for BE with PK endpoint &amp; clinical end point.</li></ul>

Biostatistician