Manager – Biostatistics (Study Statistician / Study Lead Statistician)
Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 5 – 10+ Years (Biostatistics / Clinical Trial Statistics)
Qualification: MSc / PhD in Statistics, Biostatistics, or related quantitative field
Approx Salary: ₹35 LPA – ₹65 LPA
Job Overview
Amgen is hiring a Manager – Biostatistics to support statistical analysis and study design for clinical development programs.
This role will contribute to clinical trial statistical planning, execution, and reporting, ensuring scientifically rigorous analyses that support regulatory submissions and drug development decisions.
The candidate will collaborate with clinical teams, data scientists, and regulatory stakeholders to deliver high-quality statistical outputs throughout the clinical trial lifecycle.
Key Responsibilities
1. Clinical Trial Statistical Support
Provide statistical expertise for clinical trial design and execution.
Review and contribute to Key Design Elements (KDEs) and study protocols.
Support statistical components of randomization schemes and statistical analysis plans (SAPs).
2. Data Analysis & Reporting
Generate and review Tables, Figures, and Listings (TFLs) for clinical studies.
Contribute to statistical analysis used in:
Clinical Study Reports (CSRs)
Regulatory submissions
Scientific publications
Deliver analysis summaries and insights through Flash Memos and study reports.
3. Cross-Functional Collaboration
Act as the GBS statistical lead within clinical study teams.
Collaborate with clinical development, data management, programming, and regulatory teams.
Ensure alignment between study objectives, data collection, and statistical analyses.
4. Quality & Compliance
Maintain statistical documentation in the Trial Master File (TMF).
Review deliverables from external vendors and CRO partners.
Ensure compliance with regulatory guidelines and internal quality standards.
5. Innovation & Process Improvement
Contribute to statistical methodology development in clinical research.
Support initiatives integrating AI and technology tools to streamline statistical workflows.
Participate in process improvements and operational efficiency projects.
Required Skills
Statistical & Analytical Skills
Strong knowledge of biostatistics methods used in clinical trials
Experience applying statistical modeling in drug development
Understanding of clinical study design and regulatory requirements
Technical Skills
Experience with statistical programming and analysis tools
Ability to generate and interpret clinical trial statistical outputs
Knowledge of innovative clinical trial design methodologies
Preferred Qualifications
PhD in Statistics or Biostatistics
Experience with:
Machine learning in healthcare
Real-world evidence (RWE) analytics
Electronic health record (EHR) data analysis
Clinical trial simulation
Experience working in global pharmaceutical or biotech organizations
Key Competencies
Clinical trial statistical design and analysis
Regulatory-compliant statistical reporting
Cross-functional collaboration in drug development
Data-driven decision support in clinical research
Statistical innovation and process optimization
About the Company
Amgen is a global biotechnology leader dedicated to developing innovative therapies for serious diseases. By integrating advanced science, data analytics, and precision medicine, Amgen delivers treatments that reach millions of patients worldwide.
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