Senior Director, Biostatistics

12-15 years years

Not Disclosed

Hyderabad

10 Sept. 2, 2025

Job Description

Job Type: Full Time Education: Doctorate in Statistics/Biostatistics + 12+ years post-graduate experience in pharmaceutical industry or medical research Master’s degree in Statistics/Biostatistics or related field + 15+ years post 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 (On Site)
Job ID: R-223730
Date Posted: August 30, 2025
Category: Research

Company Overview

At Amgen, our shared mission—to serve patients—drives everything we do. We are a leading global biotechnology company, collaborating worldwide to research, manufacture, and deliver innovative therapies that improve the lives of over 10 million patients. Join us for a career you can be proud of.

Position Summary

As Senior Director, Biostatistics, you will lead the India-based Biostatistics team, delivering strategic statistical direction, operational excellence, and digital innovation aligned with Amgen’s global Clinical Development strategy. You will provide functional leadership, drive seamless global execution, and contribute to Amgen’s vision of becoming a center of biostatistics excellence.

Key Responsibilities

Lead strategic statistical direction for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs).
Influence global product development decisions through strategic input.
Act as the primary statistical oversight contact in India; collaborate with global R&D, regulatory, HEOR, and clinical teams.
Oversee operational delivery of statistical activities ensuring inspection readiness, data quality, and regulatory compliance.
Build and nurture a biostatistics center of excellence in India, including hiring, onboarding, mentoring, and performance management.
Govern vendor and FSP partnerships ensuring performance standards, quality delivery, and risk mitigation.
Champion adoption and integration of new technologies such as AI, statistical automation tools, and open-source platforms.
Contribute to global initiatives in process improvement, digital innovation, and analytics capability building.
Represent Amgen’s Biostatistics function in scientific and industry forums as applicable.

Location

This role is based at Amgen India, Hyderabad (On Site).

Qualifications

Basic Qualifications (choose one):

Doctorate in Statistics/Biostatistics + 12+ years post-graduate experience in pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics or related field + 15+ years post-graduate experience in pharmaceutical industry or medical research

Preferred Skills

Extensive experience with global regulatory submissions and Health Technology Assessment (HTA)/payer collaborations
Leadership experience managing and mentoring globally distributed teams
Proven success in cross-functional stakeholder alignment
Strong analytical, problem-solving, and communication skills
Experience applying or managing AI/ML solutions; familiarity with R, Python, and automated statistical tools
Exposure to cloud platforms or data lakes (a plus)
Scientific thought leadership and publication record (preferred but not required)

What Amgen Offers

Opportunities for professional growth and learning within a global organization
Inclusive and diverse community fostering empowerment and innovation
Comprehensive Total Rewards Plan covering health, finance, work/life balance, and career benefits

How to Apply

Interested candidates can apply now through the Amgen careers portal for Job ID: R-223730

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Senior Director, Biostatistics

Job Description

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