Vimta Labs
142, IDA, Phase II, Cherlapally
Hyderabad - 500 051
Group Leader (Biostatistics)
Job Summary
Experience 5 - 7 years
Education M.Sc
Job Description
1. Perform Statistical analysis using SAS and Pharmacokinetic analysis using WinNonlin. Especially capable of doing in partial replicate design and replicate study design analysis for BE studies.
2. Providing Statistical inputs in the study protocol and review of protocols.
3. Assist in study design and calculation of sample size. Givinig sample size recommendations for Pivotal studies based on pilot study or literature data based on scientific grounds using SAS.
4. Collection of data from Bio-analytical unit and performing pharmacokinetic and statistical analysis.
5. Randomization of treatment allocation using SAS. Generation of randomization schedules for Pilot& Pivotal BA / BE studies of different study designs.
6. Preparation of SOPs as required for pharmacokinetic and Biostatistical activities and ensuring strict implementation.
7. Ability (Strong organization skills) to work and collaborate across multiple projects effectively.
8 .Prepare templates,SAS programs,SAS macros as required.
9. Review clinical study report and provide statistical conclusions.
10. Prepare and review study specific tables,figures and listing(TFL) plan.
11. Performing the statistical analysisand preparing Bio-Statistical reports as per the regulatory requirements.
12. Coordinating with reports group in report preparation and timely releasing.
13. Finally he / she required ethical behaviour and good corporate culture.
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