Biostatistician - Male candidates only

0 years

1 - 2 Lacs

Hyderabad

Posted:1 day ago| Platform: Naukri logo

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Skills Required

Biostatistics Randomization SAS Programming Sdtm PK Data Adam Statistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Axis Clinicals
Axis Clinicals

Clinical Research Organization (CRO)

Port Louis

50-100 Employees

6 Jobs

    Key People

  • Dr. Rakesh Sharma

    Chief Executive Officer
  • Ms. Maya Singh

    Director of Operations

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