Axis Clinicals is a reputed clinical research organization specializing in bioequivalence (BE) and pharmacokinetic studies. With a strong focus on regulatory compliance (USFDA, EMEA, Canada), the company provides end-to-end clinical trial solutions.
Why Join Axis Clinicals?
✔️ Hands-on experience in regulatory submissions
✔️ Opportunity to work with SAS programming in clinical research
✔️ Structured career growth in biostatistics
Role & Responsibilities:
- Provide statistical inputs for study designs (two-way, parallel, replicate, steady-state) for BE studies.
- Prepare randomization schedules as per protocol and regulatory SOPs.
- Perform data consistency checks and outlier analysis for bioanalytical & PK data.
- Conduct statistical analysis of PK data using SAS for USFDA, EMEA, and Canada submissions.
- Prepare statistical reports and Statistical Analysis Plans (SAP).
- Estimate and justify sample sizes for clinical trials.
- Detect statistical outliers as per regulatory guidelines.
- Address regulatory queries related to statistical analysis.
Eligibility Criteria:
- Education: M.Sc. in Statistics/Biostatistics (SAS certification mandatory)
- Experience: Freshers can apply
- Location: Hyderabad
- Bond: 2-year commitment (must submit 10th original marksheet)
How to Apply?
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