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Sr. Director, Statistical Programming

0-2 years
Not Disclosed
10 Sept. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Director, Global Statistical Programming

Location: Hyderabad, India (On-Site)
Job ID: R-223679
Date Posted: September 10, 2025
Category: Clinical Development


About Amgen

At Amgen, our mission is to serve patients. As one of the world’s leading biotechnology companies, we are driven by innovation, collaboration, and a commitment to improving lives. With products reaching over 10 million patients worldwide, we are expanding our global Statistical Programming capabilities, with Amgen India (AIN), Hyderabad playing a central role.

Join us for a career where you can make a real impact.


Position Overview

As Senior Director of Global Statistical Programming, you will lead Amgen’s statistical programming function at the Hyderabad site, driving operational excellence, innovation, and regulatory compliance. You will partner closely with global teams to ensure seamless execution of programming deliverables that support clinical development programs.


Key Responsibilities

  • Provide strategic and operational leadership for statistical programming within Amgen’s global framework, with site accountability in Hyderabad.

  • Oversee programming activities to ensure quality, timeliness, compliance, and inspection readiness.

  • Establish and expand a center of programming excellence at AIN through hiring, onboarding, mentoring, and performance management.

  • Drive process standardization, reusable code frameworks, and scalable programming models for efficiency and consistency.

  • Collaborate with Biostatistics, Data Management, and Regulatory Writing teams to align deliverables with program timelines.

  • Champion the use of emerging technologies such as AI, automation tools, and open-source platforms (R, Python) to enhance programming efficiency.

  • Lead global initiatives in statistical process improvement, digital transformation, and analytics capability building.


Basic Qualifications

  • Bachelor’s degree (BA/BSc) or higher in Biostatistics, Statistics, Mathematics, or related quantitative/scientific discipline.


Preferred Qualifications & Skills

  • Master’s degree (MSc) or higher in Biostatistics, Statistics, Mathematics, or related field.

  • Extensive experience with SAS programming, CDISC standards, and regulatory submissions.

  • Proven track record in leading large teams across end-to-end programming activities (study start-up to regulatory submission).

  • Proficiency with open-source tools (R, Python), automation platforms, and digital innovations.

  • Experience with AI-driven workflows in GxP environments.

  • Strong background in process innovation, standardization, and operational excellence.

  • Effective cross-functional collaboration skills in a global, matrix environment.

  • Excellent leadership, communication, and influencing skills at multiple organizational levels.


What You Can Expect from Amgen

  • Vast opportunities to learn, grow, and advance within a global organization.

  • A diverse and inclusive culture where innovation and collaboration thrive.

  • A comprehensive Total Rewards Plan including health, wealth, work-life balance, and career development benefits.