Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Biostatistics Senior Associate (Study Statistician) – Amgen

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Knowledge Management

Pharma

Libraries

Location

Hyderabad, India

Job Type

Full time (In office)

Department

Clinical – Global Biostatistics

Experience Required

4+ years of post-graduate experience as a Statistician in Pharmaceutical, Biotechnology, Clinical Research, or Medical Research settings with a Master’s degree.
2+ years of post-graduate experience with a Doctoral degree in Statistics/Biostatistics.
Experience applying statistical methodologies in clinical trials is required.

Estimated Salary Package (Market Standard)

₹18 – ₹35 LPA (approx.), depending on statistical expertise, clinical trial experience, programming skills, and interview performance.

Job Overview

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Statistical

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Pharmacy

The Biostatistics Senior Associate (Study Statistician) provides statistical expertise across clinical development programs by supporting study design, statistical analysis, clinical trial reporting, and regulatory submissions. The role involves authoring statistical documents, performing clinical trial analyses, ensuring data quality, and collaborating with cross-functional teams to deliver scientifically rigorous and compliant study outputs.

Key Responsibilities

Statistical Study Support

Provide statistical input throughout the clinical trial lifecycle.
Support study design, analysis planning, and interpretation of clinical data.
Conduct statistical analyses for:
Primary endpoints
Secondary endpoints
Exploratory analyses
Dose-level evaluations
Ensure statistical methods are scientifically appropriate and aligned with regulatory expectations.
Statistical Documentation

Author and re

📌 Biostatistics Senior Associate Hyderabad (India)
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