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Director Biostatistics

4-8 years
$217,725 – $246,888
10 Nov. 4, 2025
Job Description
Job Type: Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Director, Biostatistics

Location: United States – Remote
Job ID: R-228488
Work Location Type: Remote
Date Posted: October 28, 2025
Category: Clinical
Salary Range: $217,725 – $246,888 USD
Additional Locations: United States – Remote


About Amgen

Since 1980, Amgen has been pioneering biotechnology solutions to address some of the world’s toughest diseases. Guided by its mission “To serve patients”, Amgen focuses on four core therapeutic areas — Oncology, Inflammation, General Medicine, and Rare Diseases — impacting millions of patients globally.

At Amgen, you’ll be part of a collaborative, innovative, and science-driven culture that empowers you to make a lasting impact on both patients and your own professional journey.


Position Summary

The Director of Biostatistics will lead the statistical programming and strategy for a portfolio of complex programs within Amgen’s clinical development organization. This role drives statistical excellence across all phases of product development — from early design through evidence generation, regulatory submission, and commercialization.

You will act as the primary point of contact for statistical strategy, ensuring high-quality, scientifically sound, and innovative data-driven decisions in alignment with Amgen’s global evidence generation objectives.


Accountabilities

  • Lead and oversee statistical program strategy for a portfolio of complex programs.

  • Develop and implement Evidence Generation Plans (EGPs) in collaboration with Strategic Development, Statistical Innovation, Global Medical Affairs, and regional leads.

  • Partner with cross-functional evidence-generation teams to ensure high statistical integrity and excellence across the product lifecycle.


Key Responsibilities

1. Statistical Excellence

  • Drive and communicate the application of innovative and standard statistical methodologies, clinical trial designs, and data analysis strategies.

  • Collaborate with CfDA Design & Innovation to implement novel, fit-for-purpose study designs balancing speed, quality, and cost.

  • Translate data and evidence needs into comprehensive Evidence Generation Plans (EGP) and align them with product strategy.

  • Lead the creation and oversight of Global Statistical Strategic Plans (GSSP) to ensure statistical alignment across programs.

  • Oversee statistical deliverables — including study protocols, SAPs, TFL shells, randomization specs, and data file definitions.

  • Provide statistical support for regulatory submissions, HTAs, payer negotiations, and benefit–risk assessments.

  • Serve as a key statistical contact for regulatory agencies, addressing queries in partnership with the Principal Statistician.

  • Contribute to cross-functional analytical strategies (e.g., PK/PD modeling, biomarker analytics).

2. Resource & Team Management

  • Lead and manage a global biostatistics team to meet annual department goals.

  • Oversee staff development, mentoring, and succession planning.

  • Ensure effective utilization of supplier and outsourced resources.

  • Maintain and update Amgen Policies, SOPs, and controlled documents relevant to biostatistics.


Qualifications

Basic Qualifications

  • Doctorate (PhD) in Statistics/Biostatistics with 8+ years of post-graduate statistical experience in the pharmaceutical or medical research industry
    OR

  • Master’s degree in Statistics/Biostatistics (or related quantitative field) with 10+ years of relevant post-graduate statistical experience

Preferred Qualifications

  • PhD in Statistics/Biostatistics with 8+ years of experience (including 4+ years in Oncology/Hematology)
    OR

  • Master’s degree with 12+ years of experience (including 4+ years in Oncology/Hematology)

  • Demonstrated expertise in:

    • Complex trial design and analysis

    • Regulatory submission strategy

    • Leadership of global statistical teams

  • Proven ability to integrate innovation (adaptive designs, Bayesian methods, etc.) into clinical development

  • Excellent communication, influencing, and leadership skills


Compensation & Benefits

Expected Annual Salary (San Francisco): $240,284 – $280,634 USD
(Actual compensation may vary based on skills, experience, and qualifications.)

Amgen Total Rewards Plan includes:

  • Comprehensive health, dental, and vision coverage for staff and dependents

  • Retirement and Savings Plan with generous company contributions

  • Life and disability insurance, flexible spending accounts

  • Annual performance-based bonus or sales incentive plan (for field roles)

  • Stock-based long-term incentives

  • Award-winning paid time-off plans

  • Flexible remote and hybrid work models


Application Details

  • No specific application deadline — applications accepted until position is filled.

  • Applicants may redact age-identifying information (e.g., birth date, graduation years).


Equal Opportunity Statement

Amgen is an Equal Opportunity Employer committed to diversity, inclusion, and ethical excellence. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

Amgen will provide reasonable accommodations for individuals with disabilities in the hiring process or in performing essential job functions.


Apply Now: [careers.amgen.com]
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