Study Statistician
Location: India, Hyderabad
Work Type: On-Site
Job ID: R-226273
Date Posted: November 3, 2025
Category: Clinical Development
Overview
Amgen is expanding its global Biostatistics function, with Amgen India (AIN) playing a critical role in delivering integrated statistical support for clinical programs worldwide. The Study Statistician will contribute to the design, execution, and interpretation of statistical analyses for clinical studies, ensuring scientific rigor, regulatory compliance, and timely delivery of high-quality outputs. This position supports end-to-end clinical development activities and collaborates closely with cross-functional teams to drive data-driven decision-making.
Key Responsibilities
Provide statistical expertise for study design documents, including Key Design Elements (KDE), clinical protocols, and statistical components.
Serve as the Global Biostatistics (GBS) lead within Clinical Study Teams to ensure protocol adherence, high-quality data collection, and alignment between study objectives and data requirements.
Oversee statistical contributions to randomization specifications, Statistical Analysis Plans (SAPs), TFL shells, submission data specifications, and other essential study documentation.
Collaborate with clinical, medical, and data science teams to produce scientifically robust analysis outputs such as Tables, Figures, Listings (TFLs), Flash Memos, Clinical Study Reports (CSRs), and clinical publications.
Maintain accuracy and compliance of statistical components within the Trial Master File (TMF).
Communicate study findings, analysis insights, and statistical considerations to internal and external stakeholders.
Contribute to defining signal detection thresholds and participate in safety-related statistical assessments.
Review deliverables from external partners and ensure alignment with quality expectations and regulatory standards.
Stay current with advancements in statistical methodology, regulatory requirements, and innovative trial design.
Support development and review of Amgen Policies, SOPs, and process documents.
Contribute to operational excellence and continuous improvement initiatives.
Assist in developing technology solutions, including AI-based automation, to enhance statistical workflows.
Manage individual priorities and coordinate with peers to meet project timelines and quality commitments.
Basic Qualifications
MSc or PhD in Statistics, Biostatistics, or a related quantitative discipline.
Approximately 4–5 years of relevant industry experience in clinical development or pharmaceutical statistics.
Demonstrated ability to apply statistical methodologies in clinical trials and regulatory settings.
Preferred Qualifications and Skills
Doctorate in Statistics or Biostatistics.
Experience in machine learning, real-world data analytics, EHR data, clinical trial simulation, or advanced quantitative approaches.
Experience across the full drug development lifecycle.
Strong cross-cultural collaboration skills and ability to work effectively in globally distributed teams.
Knowledge of innovative trial design, regulatory guidance, and modern biostatistical strategies.
Familiarity with AI-driven tools and an interest in leveraging technology to streamline statistical processes.
What You Can Expect
Opportunities for professional development within a global biotechnology organization.
A diverse, inclusive, and collaborative work environment where innovation is encouraged.
A comprehensive Total Rewards program covering health, financial well-being, work-life balance, and career growth.
How to Apply
Candidates meeting the qualifications may submit their applications through the official Amgen careers portal.
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Donegal |China :
China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
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Sofia |Canada :
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Montreal |Chile :
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Hammond | Riga | Leinster | Lousiana | Thailand | Victoria | Remote - Africa | French | Bishop | Xzagreb | Hungary | Melbourne | Zaragoza | Medan | Belgium | Blue Bell | Tulsa | Green Way | Remote, USA | Remote - Middle East | Remote | Nairobi | Slovakia | Minnesota | Lenexa | Texas | Springville | Bountiful | Manipal | McFarland | Castlebar | Ireland | Remote - South America (Latin Americal) | Remote - Europe | Faridabad | Switzerland |Bucharest :
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Rabigh | Khulais | Jeddah | Najran | King Abdullah Economic City | Riyadh |Nišava District :
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