Biostatistical Programming Manager
Location: Hyderabad, India
Work Type: On-Site
Job ID: R-228907
Category: Research
Job Overview
Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) serving as a core hub for global statistical programming delivery. The organization is seeking a Biostatistical Programming Manager to lead end-to-end programming activities across one or more clinical studies and guide a team of statistical programmers in delivering high-quality, compliant, and timely outputs.
This leadership position combines strategic oversight with technical execution, supporting clinical development, regulatory submissions, integrated analyses, and cross-functional collaboration. The role offers significant exposure to global clinical operations, modern programming methodologies, and digital transformation initiatives in biotechnology.
Key Responsibilities
Study Leadership and Programming Strategy
Serve as Study Lead Programmer (SLP) for assigned studies or projects.
Define programming strategy and ensure delivery of timelines, quality, and compliance.
Lead integrated programming activities for regulatory submissions involving multiple studies.
Coordinate with statisticians and study teams to define programming scope and timelines.
Programming and Specification Development
Develop and maintain programming specifications, including SDTM and ADaM datasets.
Provide hands-on programming support for complex deliverables.
Manage computing environments, lookup tables, and technical resources required for project execution.
Cross-Functional Collaboration
Represent Global Statistical Programming (GSP) in Clinical Study Team (CST) meetings.
Provide programming input during study start-up, including CRF development, database specifications, IVRS design, and data cleaning strategies.
Initiate and lead cross-functional discussions as needed to resolve study-level programming challenges.
Team Leadership and Oversight
Assign and manage workload for statistical programmers to ensure timely and accurate deliverables.
Provide technical leadership, training, and mentorship to programming team members.
Coordinate data issue tracking and resolution across functions.
Ensure alignment of programming outputs across multiple studies within a product.
Experience Required
Basic Qualifications
Bachelor’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a quantitative scientific discipline.
Minimum 6 years of statistical programming experience in a clinical development environment.
Strong expertise in SAS programming, including SAS/STAT.
Deep understanding of clinical trial processes and data standards.
Demonstrated experience leading study-level programming activities to completion.
In-depth knowledge of CDISC SDTM, ADaM, and Define standards.
Experience with data quality and compliance tools.
Strong project management, communication, and cross-cultural collaboration skills.
Preferred Qualifications
Master’s degree or higher in Statistics, Biostatistics, Mathematics, or similar field.
Experience with regulatory submissions for drug approvals.
Familiarity with R, Python, and open-source programming frameworks.
Exposure to automation platforms and emerging digital tools in statistical programming.
Ability to guide teams on technical and process-related challenges.
What to Expect at Amgen
Opportunities for professional growth within a global biotechnology organization.
A collaborative workplace that values innovation, inclusion, and continuous learning.
Comprehensive Total Rewards Plan covering health, financial, and career development benefits.
An environment where scientific excellence and data integrity are central to the mission of serving patients worldwide.
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