Manager, Biostatistics (Study Lead Statistician)
Location: Hyderabad, India (On-site)
Job ID: R-235507
Category: Clinical Development
Posted Date: February 02, 2026
Employment Type: Full-Time
Amgen continues to strengthen its global Biostatistics organization, with Amgen India (AIN) serving as a key hub for integrated delivery and functional leadership. The Manager, Biostatistics (Study Lead Statistician) will provide scientific and technical leadership for statistical activities across clinical studies, ensuring rigorous study design, high-quality analyses, and regulatory compliance throughout the drug development lifecycle.
This role offers the opportunity to contribute to innovative clinical development programs while collaborating with global, cross-functional teams in a highly regulated biopharmaceutical environment.
Provide statistical leadership, review, and quality control for study design documents, including Key Design Elements (KDEs) and clinical protocols.
Serve as the Global Biostatistics (GBS) lead on the Clinical Study Team leadership group, supporting trial execution, risk assessment, and alignment between study objectives and data collection.
Oversee statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Tables, Figures and Listings (TFLs), submission data file specifications, and related study documentation.
Collaborate cross-functionally to deliver scientifically robust and regulatory-compliant statistical outputs, including TFLs, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and internal communications.
Ensure statistical documentation within the Trial Master File (TMF) is complete, accurate, and inspection-ready.
Communicate study findings, analyses, and insights effectively to internal and external stakeholders.
Contribute to defining signal detection thresholds and statistical decision-making frameworks.
Review deliverables from external vendors and partners to ensure quality and compliance.
Stay current with advancements in statistical methodologies, innovative trial designs, and regulatory expectations in drug development.
Support the review and enhancement of Amgen policies, SOPs, and controlled documents.
Contribute to continuous improvement initiatives, operational efficiencies, and standardization of statistical processes.
Assist with the development and adoption of technology-enabled solutions, including AI-driven tools, to improve statistical workflows.
This position is based at Amgen India, Hyderabad.
Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative discipline.
Approximately 3–5 years of relevant industry experience in clinical development or pharmaceutical research.
Demonstrated ability to apply statistical methods to clinical trial design, analysis, and interpretation.
Strong understanding of regulatory expectations and statistical practices across the drug development lifecycle.
Excellent written and verbal communication skills in English.
Doctoral degree in Statistics or Biostatistics.
Experience with machine learning, real-world data analytics, electronic health record (EHR) data, clinical trial simulations, or related advanced analytics applications.
Broad experience across the full lifecycle of drug development.
Proven ability to work effectively within globally distributed, cross-cultural teams.
At Amgen, employees are empowered to contribute to life-changing therapies that serve patients worldwide. The organization offers extensive learning and career development opportunities, a diverse and inclusive workplace culture, and a comprehensive total rewards program supporting health, financial well-being, work-life balance, and long-term career growth.
Apply now on thepharmadaily.com to advance your career as a Study Lead Statistician within a global biopharmaceutical leader.
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Auckland |New Zealand :
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