Job Title: Biostatistical Programming Manager
Location: India – Hyderabad
Job ID: R-228907
Work Location Type: On Site
Date Posted: November 02, 2025
Category: Research
About Amgen
At Amgen, every role contributes to a shared mission — to serve patients.
As one of the world’s leading biotechnology companies, Amgen’s collaborative teams research, manufacture, and deliver life-changing medicines that reach over 10 million patients globally.
Join us to be part of something bigger — science that changes lives.
Position Overview
Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions.
The Biostatistical Programming Manager will serve as the Study Lead Programmer (SLP) for one or more clinical studies and lead a team of statistical programmers.
The role involves leading end-to-end statistical programming activities, managing project deliverables, and supporting regulatory submissions.
Key Responsibilities
Serve as Study Lead Programmer (SLP) for one or multiple studies/projects.
Define programming strategies and ensure delivery within timelines, quality, and compliance standards.
Lead and manage programming activities for integrated analyses involving multiple studies (e.g., regulatory submissions).
Collaborate with statisticians and study teams to define programming scope and detailed timelines.
Create and maintain programming specifications such as SDTM and ADaM datasets.
Represent GSP in Clinical Study Team (CST) meetings and provide programming input during study start-up.
Review and contribute to CRF development, database specifications, and IVRS specifications.
Perform hands-on statistical programming for complex deliverables.
Manage and monitor data issue reporting and resolution.
Coordinate with other SLPs to ensure consistency across studies.
Provide technical leadership, training, and guidance to team members.
Support product-level programming activities as delegated by Global Programming Lead (GPL) or Programming Execution Lead (PEL).
Basic Qualifications
Bachelor’s degree (BA/BSc or higher) in Biostatistics, Statistics, Mathematics, Computer Science, or related quantitative/scientific fields.
Minimum 6 years of statistical programming experience in a clinical development environment.
Strong understanding of clinical trial processes, from data collection to reporting.
Proven experience leading end-to-end programming activities for studies.
Expertise in CDISC standards – SDTM, ADaM, Define.xml.
Proficiency in SAS (including SAS/STAT).
Experience with data quality and compliance tools.
Excellent project management, communication, and cross-cultural collaboration skills.
Ability to guide and mentor junior programmers.
Preferred Qualifications
Master’s (MSc) or higher in Biostatistics, Statistics, Mathematics, or related field.
Familiarity with open-source programming tools such as R or Python.
Experience with automation platforms and emerging technologies in statistical programming.
Prior regulatory submission experience for drug approvals.
What You Can Expect (Thrive at Amgen)
Vast learning and career mobility opportunities across global teams.
Inclusive and diverse work culture that empowers innovation.
Comprehensive Total Rewards Plan — covering health, financial, work-life balance, and career growth benefits.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer.
Applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Reasonable accommodations are available for individuals with disabilities throughout the application and interview process.
Apply Now: [Amgen Careers – Apply]
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