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Senior Director , Biostatistics

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, Biostatistics

Location: Hyderabad, India
Job ID: R-223730
Category: Clinical Development
Work Location Type: On-Site
Date Posted: August 30, 2025


About Amgen

At Amgen, our mission is simple yet profound: to serve patients. This mission drives us to innovate, collaborate globally, and deliver life-changing biotechnology solutions that reach more than 10 million patients worldwide. Join us in building a career you can be proud of.


Role Overview

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) serving as a strategic hub for integrated delivery and functional leadership. As Senior Director, Biostatistics, you will:

  • Lead the India-based Biostatistics team.

  • Drive statistical strategy, operational excellence, and digital innovation aligned with Amgen’s global Clinical Development strategy.

  • Provide local functional leadership while contributing to global clinical development through seamless execution and tech-enabled transformation.


Key Responsibilities

  • Provide strategic statistical leadership for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs).

  • Serve as the primary statistical leader in India, collaborating with global R&D, regulatory, HEOR, and clinical teams.

  • Oversee operational delivery of statistical activities, ensuring compliance, inspection readiness, and data quality.

  • Build and shape a center of Biostatistics excellence at Amgen India, including hiring, onboarding, mentoring, and performance management.

  • Govern vendor and FSP partnerships, ensuring delivery quality, performance alignment, and risk mitigation.

  • Champion digital innovation by piloting and integrating AI, machine learning, automation tools, and open-source platforms.

  • Represent Amgen Biostatistics in global initiatives and external scientific or industry forums.


Qualifications

Basic Qualifications

  • Doctorate (PhD) in Statistics/Biostatistics with 12+ years post-graduate experience in pharmaceutical/medical research, OR

  • Master’s degree in Statistics/Biostatistics (or related field with high statistical content) with 15+ years post-graduate experience in pharmaceutical/medical research.

Preferred Qualifications

  • PhD in Statistics/Biostatistics with 12+ years industry experience, OR

  • Master’s in Statistics/Biostatistics with 15+ years industry experience.

  • Experience with global regulatory submissions and HTA/payer collaborations.

  • Proven leadership in building and managing globally distributed teams.

  • Strong record of cross-functional stakeholder engagement.

  • Expertise in AI/ML applications, with hands-on knowledge of R, Python, and automated statistical tools.

  • Exposure to cloud platforms or data lakes.

  • Track record of scientific thought leadership or publications (preferred but not required).


What We Offer

  • Opportunities for continuous learning and professional growth within a global organization.

  • A diverse, inclusive, and collaborative community where every idea matters.

  • A comprehensive Total Rewards Plan including:

    • Health, financial, and wellness benefits

    • Work-life balance programs

    • Career development support


🔹 Location: Hyderabad, India (Amgen India – AIN)
🔹 Apply Now: [Amgen Careers Portal]