Posted:1 week ago|
Platform:
Work from Office
Full Time
Salary : 2.2LPA - 14k Change in Hand per month (after deductions of PF,ESI,PT) 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Must have a SAS training Certificate. Role & responsibilities: 1. Providing inputs related to statistical methods for various study design ( two way, parallel, replicate, study state etc) and protocol preparation considering the requirements of BE studies for USFDA, EMEA, CANADA etc submission. 2. Preparation of randomization schedule as per the protocols and applicable SOPs for following study designs ( two way, parallel, replicate, study state etc). 3. Data checking for consistency and outlier analysis for bio-analytical data as well as PK data. 4. Perform statistical analysis of PK data using SAS software for different study designs ( two way, parallel, replicate, study state etc) for USFDA, EMEA, CANADA etc submission. 5. Preparation of statistical report and SAP. 6. Provide sample size estimation/ justification. 7. Statistical outlier detection as per the concerned protocol or regulatory requirements. 8. Response preparation for addressing the regulatory queries related to statistical aspects.
Axis Clinicals
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