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Job Title Biostatistician
Job Description

Qualification: B.Sc / M.Sc (Statistics)

To calculate primary and secondary pharmacokinetic parameter through Phoenix WinNonlin software.
To analyze pharmacokinetic data by applying appropriate statistical method using SAS software.
Generation of Randomization for clinical trials and Random sample number for chromatogram selections.
To execute randomization schedules through statistical analysis software.
Preparation of data sets as per the regulatory requirements.
To provide pharmacokinetic and statistical results for the final study report.
Generation of tables and charts for pharmacokinetic analysis.
Preparation and Validation of CDISC (SDTM and ADaM) Datasets.
Preparation and review of Annotation of CRF as per the SDTM standards.
To provide pharmacokinetic and statistical inputs for study protocol.
Estimation and justification for Sample Size using the software like Statistical Analysis System/Software (SAS).
To submit all completed study-related documents to archivist.
To write, revise and ensure implementation of pharmacokinetic and statistical SOPs as per requirements.
Handling of regulatory and sponsor quires.
To ensure compliance to GCP/GLP guidelines for all pharmacokinetic and statistical evaluations.
To calculate the weighting factor for quantitative analysis .
To execute any other duties assigned by Head-Operations.

No of Positions 1
Location Hyderabad
Required Experience 2-6 years of work experience
Position On Date 2022-06-07
Salary Up to 6 LPA
Position Closed By
E-Mail hradmin@talentcohr.com
Contact No. 7738249852