Study Statistician
Location: Hyderabad, India
Category: Clinical Development
Work Type: On-Site
Job ID: R-226273
Date Posted: November 03, 2025
Position Overview
Amgen is seeking a highly skilled Study Statistician to join its expanding Biostatistics function in Hyderabad, India. This role supports global clinical development programs by delivering high-quality statistical expertise, ensuring regulatory compliance, and contributing to scientifically rigorous study analyses. The Study Statistician will collaborate closely with cross-functional teams and play a key role in advancing Amgen’s mission to serve patients worldwide.
About Amgen
Amgen is a global biotechnology leader focused on discovering, developing, and delivering innovative medicines that improve patient outcomes. With research, manufacturing, and data-driven operations across multiple countries, Amgen supports more than 10 million patients each year. The Biostatistics team plays an essential role in supporting clinical trials, regulatory submissions, and evidence generation.
Key Responsibilities
Provide statistical input, review, and quality control for study design documents, Key Design Elements (KDE), and clinical protocols.
Serve as the Global Biostatistics Services (GBS) lead for Clinical Study Teams and ensure trial execution aligns with study objectives.
Develop and oversee statistical deliverables including SAPs, randomization specifications, TFLs, datasets, and submission documentation.
Collaborate with cross-functional colleagues to produce reliable, valid, and scientifically sound analysis outputs for CSRs, Flash Memos, and publications.
Maintain and update statistical documentation within the Trial Master File (TMF).
Communicate analytical findings, insights, and study-specific outcomes to internal and external stakeholders.
Contribute to defining signal-detection thresholds for study monitoring.
Review deliverables from external vendors and ensure they meet Amgen’s quality standards.
Stay informed about advancements in statistical methodologies, innovative trial designs, and regulatory expectations in drug development.
Support review of SOPs, policies, and controlled documents.
Contribute to process improvement initiatives to enhance operational efficiency.
Assist in developing AI-enabled tools and technologies designed to streamline statistical workflows.
Effectively manage priorities to meet timelines and ensure consistent delivery of high-quality outputs.
Required Qualifications
MSc or PhD in Statistics, Biostatistics, or a related quantitative field.
4–5 years of relevant industry experience in clinical development, biostatistics, or pharmaceutical research.
Proven expertise in applying statistical methods to clinical trial data.
Preferred Qualifications
Doctorate degree in Statistics or Biostatistics.
Experience in machine learning, real-world data analytics, electronic health record (EHR) data analysis, or clinical trial simulation.
Exposure to end-to-end drug development and regulatory submissions.
Ability to work effectively with global, cross-cultural teams.
Strong understanding of innovative trial designs and modern statistical practices.
Familiarity with AI-driven tools and an interest in technology-enabled workflow optimization.
What You Can Expect at Amgen
Opportunities to grow and develop within a global, research-driven organization.
A diverse and inclusive work culture that values innovation and scientific excellence.
A competitive Total Rewards program covering health, financial well-being, work-life balance, and career development.
A supportive environment where ideas and contributions are recognized.
Apply Now
If you are passionate about statistical innovation, clinical research, and contributing to transformational medicines, apply now to join Amgen as a Study Statistician.
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