Biostatistician
Posted on :
07-03-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
07-03-2024
Job Description
Req ID : 2601463
Job Description:
- Experience of handling bioequivalence studie including various study designs.
- Calculate sample size required for the study.
- Generate randomization schedule.
- Estimate pharmacokinetic parameters and statistical analysis.
- Perform statistical analy.ses and interpret the results.
- Work on five to six studies/work tasks simultaneously.
- Define methodology of the clinical trial studies.
- Prepare and review the statistical methodolog/ sections(s) of study reports.
- Prepare and review statistical analysis plan (SAP) tables figures and listings according to study design and regulatory requirement.
- Preoare/review protocols including study design sample size and statistical methodologies.
- Development modification & validation of SAS programs as per requirement.
- Develop and maintain statistical programs as necessary to perform analyses to prepare data displays and to verify data accuracy.
- All statistical analysis performed using SAS programs.
- To ensure the compliance to GCP/GLP guidelines for the all statistical evolution.
- Sound knowledge of regulatory guidance documents such as ICHE3 and ICHE9.
- Prepare and revision of standard operating procedure (SOPs) as per need and ensure implementation.
- Prioritize and coordinate biostatistical support of assigned projects.
Employment Type
Full Time
Company Industry
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