Job Title:
Senior Director, Global Statistical Programming
Job Details:
Job ID: R-223679
Location: India – Hyderabad
Work Type: On-site
Posted Date: August 29, 2025
Category: Clinical Development
Company: Amgen
About Amgen:
At Amgen, we believe in defying imagination to serve patients around the globe. As one of the world’s leading biotechnology companies, our mission is to serve patients, which fuels our innovation and collaboration across more than 10 million lives impacted worldwide.
Role Overview:
As Senior Director of Statistical Programming, you will lead the Hyderabad-based Amgen India (AIN) programming team and play a critical role in global clinical development. This role involves strategic leadership, operational execution, and innovation in statistical programming, contributing directly to Amgen's regulatory and scientific deliverables.
Key Responsibilities:
Leadership & Oversight:
Lead statistical programming activities in Amgen India (AIN) aligned with Amgen’s global framework.
Ensure quality, timeliness, compliance, and inspection readiness in programming deliverables.
Provide strategic site leadership to build and grow a center of programming excellence.
Team & Talent Management:
Oversee hiring, onboarding, mentoring, and performance management of the programming team.
Foster a culture of innovation, collaboration, and continuous improvement.
Process Optimization & Innovation:
Drive standardization, reusable code frameworks, and scalable programming models.
Implement new technologies like AI, automation tools, and open-source platforms to enhance efficiency.
Lead or contribute to global initiatives in digital innovation, analytics, and process improvement.
Cross-Functional Collaboration:
Work closely with Biostatistics, Data Management, and Regulatory Writing teams to meet project timelines.
Align programming strategy with clinical development goals and regulatory submission requirements.
Qualifications:
Basic Requirements:
Bachelor’s degree (BA/BSc or higher) in Biostatistics, Statistics, Mathematics, or other quantitative/scientific disciplines.
Preferred Qualifications:
Master’s degree (MSc) or higher in a related quantitative field.
Proven experience in:
SAS programming and CDISC standards.
Global regulatory submissions.
Leading large teams through end-to-end clinical study programming.
Familiarity with:
Open-source tools (R, Python).
Automated workflows, including Agentic AI in a GxP environment.
Strong leadership and communication skills, with a track record of cross-functional collaboration in a global matrix environment.
Ability to drive process innovation, implement standardization strategies, and deliver high-quality outputs.
Why Join Amgen:
Amgen offers a culture where you can thrive professionally and personally:
Access to global career development opportunities.
A diverse and inclusive workplace that encourages innovation.
Comprehensive Total Rewards Plan including:
Health, finance, and wellness benefits.
Work/life balance programs.
Career growth resources.
Application:
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