Biostatistical Programming Manager
Location: Hyderabad, India (On-site)
Job ID: R-236378
Category: Clinical Development
Posted Date: February 02, 2026
Employment Type: Full-Time
Amgen is continuing to expand its Global Statistical Programming (GSP) organization, with Amgen India (AIN), Hyderabad serving as a strategic center for integrated, global delivery. The Biostatistical Programming Manager will play a pivotal leadership role, serving as the Study Lead Programmer (SLP) for one or more clinical studies and managing end-to-end statistical programming activities across the study lifecycle, including regulatory submissions.
This position combines hands-on technical expertise with people and project leadership, offering the opportunity to drive high-impact clinical development programs within a global biopharmaceutical environment.
Lead one or multiple clinical studies or projects end-to-end, assuming full responsibilities of the Study Lead Programmer (SLP).
Define and execute programming strategies to ensure timely, high-quality, and compliant deliverables.
Oversee and manage all statistical programming activities, including integrated analyses across multiple studies for regulatory submissions.
Partner with statisticians and cross-functional study teams to define programming scope, timelines, and deliverables.
Develop, review, and maintain programming specifications, including SDTM, ADaM, and associated documentation.
Represent Global Statistical Programming (GSP) within Clinical Study Team (CST) meetings and cross-functional forums.
Provide programming input during study start-up activities, including CRF design, database specifications, IVRS reviews, and data quality planning.
Perform hands-on statistical programming for complex or high-risk deliverables as needed.
Allocate and manage programming resources, ensuring workload balance and delivery excellence across the team.
Provide technical leadership, mentoring, and training to statistical programmers.
Coordinate data issue tracking, resolution, and quality review processes.
Collaborate with other Study Lead Programmers to ensure consistency across studies within a product or program.
Manage technical project components such as computing environments, standards, and reusable tools.
Support product-level responsibilities as assigned by Global Programming Leadership.
This role is based at Amgen India, Hyderabad.
Bachelor’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative or scientific discipline.
Minimum of 6 years of statistical programming experience within a clinical development or pharmaceutical research environment.
Proven experience leading and managing statistical programmers and delivering studies end-to-end.
Strong understanding of clinical trial processes, from data collection through analysis and reporting.
Advanced proficiency in SAS, including extensive experience with SAS/STAT and clinical trial reporting.
In-depth knowledge and practical implementation experience with CDISC standards (SDTM, ADaM, Define.xml).
Experience using data quality, validation, and compliance checking tools.
Demonstrated project management skills with the ability to manage multiple studies simultaneously.
Excellent written and verbal communication skills in English.
Ability to work effectively in a globally distributed, cross-cultural team environment.
Willingness and ability to mentor team members on both technical and process-related topics.
Master’s degree or higher in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
Experience with open-source programming tools such as R and Python, automation frameworks, and emerging technologies in statistical programming.
Prior experience supporting regulatory submissions for drug approvals.
Amgen offers a collaborative, innovation-driven culture where employees contribute to life-changing therapies for patients worldwide. Team members benefit from continuous learning opportunities, global career mobility, and a comprehensive total rewards program supporting health, financial security, work-life balance, and long-term professional growth.
Apply now on thepharmadaily.com to advance your leadership career in biostatistical programming with a global biotechnology leader.
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