Biostatistical Programming Manager
Location: Hyderabad, India
Category: Research – Statistical Programming
Work Type: On-Site
Job ID: R-228907
About the Role
Amgen is expanding its Global Statistical Programming (GSP) capabilities in India and is seeking an experienced Biostatistical Programming Manager to lead statistical programming activities for clinical studies. This role serves as a Study Lead Programmer (SLP) for multiple projects while overseeing end-to-end programming execution, regulatory submission support, and cross-functional collaboration.
The position plays a central role in delivering high-quality statistical outputs, ensuring compliance with global standards, and guiding programmers through complex analytical challenges.
Key Responsibilities
Lead one or more clinical studies or projects as the Study Lead Programmer, managing all programming responsibilities end-to-end.
Establish and execute programming strategies, ensuring timely, high-quality, and compliant study deliverables.
Manage and oversee integrated analysis programming tasks, including regulatory submission-related activities.
Collaborate with statisticians and study teams to define programming scope and delivery timelines.
Develop and maintain SDTM, ADaM, and related programming specifications for assigned studies.
Represent Global Statistical Programming (GSP) in Clinical Study Team (CST) meetings.
Provide programming input during study start-up activities including CRF development, database specifications, IVRS reviews, and data quality checks.
Initiate and participate in cross-functional discussions to support efficient study execution.
Perform hands-on statistical programming for complex deliverables and critical study outputs.
Assign and monitor work across statistical programmers to ensure aligned, consistent, and timely outcomes.
Ensure effective issue tracking, reporting, and resolution throughout the study lifecycle.
Coordinate with other Study Lead Programmers to maintain consistency across studies within the same product.
Provide technical leadership, training, and process guidance to programming teams.
Manage technical aspects of projects including programming environments and study-specific utilities.
Support product-level responsibilities assigned by the Global Programming Lead (GPL) or Programming Execution Lead (PEL).
Qualifications and Experience Required
Basic Qualifications
BA/BSc or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative field.
Minimum 6 years of statistical programming experience within a clinical development environment.
Strong understanding of clinical trial processes, from data collection through analysis and reporting.
Proven expertise in statistical programming using SAS, including SAS/STAT.
Demonstrated experience leading statistical programmers and managing end-to-end study programming activities.
In-depth knowledge of the latest CDISC standards, including SDTM, ADaM, and Define.
Experience with data quality and compliance tools.
Strong project management capabilities and ability to manage multiple projects concurrently.
Excellent verbal and written communication skills in English.
Ability to work effectively within global, cross-cultural, and matrixed teams.
Capability to guide and mentor programming team members.
Preferred Qualifications
MSc or higher in Biostatistics, Statistics, Mathematics, or related disciplines.
Experience with open-source programming technologies such as R or Python, as well as automation platforms.
Prior experience contributing to regulatory submissions for drug approvals.
Why Join Amgen?
Broad learning and career progression opportunities across a global biotechnology organization.
Inclusive and diverse workplace that values collaboration, innovation, and continuous improvement.
Comprehensive Total Rewards Plan covering health, financial well-being, work-life balance, and career development.
Apply Now
Advance your career in biostatistics and clinical programming by joining a global leader in biotechnology. Submit your application today.
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