Biostatistics Associate Director – Exploratory Analysis
Location: United States – Remote
Job ID: R-223805
Date Posted: August 25, 2025
Work Type: Remote
Category: Clinical
Salary Range: $175,519 – $207,953 USD
(Final salary may vary based on skills, experience, and qualifications)
About Amgen
At Amgen, our shared mission—to serve patients—fuels our work in biotechnology. We’re global collaborators dedicated to researching, manufacturing, and delivering breakthrough therapies across four key therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Disease
We reach over 10 million patients worldwide each year and are committed to helping people live longer, fuller lives.
Role Overview
The Associate Director, Biostatistics for Exploratory Analysis plays a critical role in advancing Amgen’s Precision Medicine efforts. You will implement exploratory biostatistical strategies, lead cross-functional projects, and provide statistical guidance across clinical development, biomarker co-development, and companion diagnostics (CDx).
Key Accountabilities
Provide dedicated statistical support for Precision Medicine initiatives.
Lead and implement exploratory biostatistical strategies and technical solutions within clinical studies or products.
Offer strategic and technical leadership in exploratory data analysis, planning, and execution.
Serve as the Exploratory Biostatistics Group (EBG) lead for Evidence Generation Teams (EGT) or Clinical Study Teams (CST) as needed.
Ensure alignment with Amgen’s policies, statistical standards, and industry best practices.
Key Responsibilities
Deliver sound statistical guidance in clinical development, biomarker analysis, and CDx co-development.
Author or review statistical analysis plans, technical reports, and publication deliverables.
Promote and implement standardized, high-quality statistical practices and analysis methodologies.
Oversee contributions to statistical documentation (e.g., SAPs, TFL shells, submission datasets).
Collaborate cross-functionally to ensure robust, scientifically rigorous outputs (TFLs, Flash Memos, CSRs, publications).
Guide and mentor statisticians (internal and FSPs); provide oversight and coaching as needed.
Participate in process improvement initiatives and innovation-driven projects.
May lead external contractors and serve as the biostatistical lead for a product or disease area.
Basic Qualifications
One of the following:
Doctorate degree and 2 years of relevant experience
Master’s degree and 6 years of relevant experience
Bachelor’s degree and 8 years of relevant experience
Associate’s degree and 10 years of relevant experience
High school diploma / GED and 12 years of relevant experience
Preferred Qualifications
8+ years of post-graduate statistical experience in the pharmaceutical or medical research industry
Experience across the drug development lifecycle (pre-clinical to post-marketing)
Clinical trial biomarker (CTA) and CDx co-development experience
Involvement in regulatory interactions (e.g., CDER, CDRH) for drugs or diagnostic devices
Expertise in exploratory biomarker analysis and innovative trial design
Strong track record contributing to regulatory submissions and scientific publications
In-depth understanding of regulatory guidelines and statistical best practices
Core Competencies
Scientific / Technical Leadership
Expert knowledge of statistical methods in clinical and biomarker research
Proven experience in randomized and non-randomized trial design
Strong analytical thinking and problem-solving abilities
Highly proficient with statistical software (e.g., SAS, R)
Deep understanding of drug development operations
People / Project Management
Ability to explain complex statistical concepts to non-statistical audiences
Leadership in global, cross-functional teams
Strong project planning, prioritization, and delivery skills
Experience managing and mentoring FSP statisticians and external collaborators
Clear, effective written and verbal communication skills
Cross-cultural sensitivity and adaptability
What Amgen Offers
Amgen is committed to supporting your career and well-being with a comprehensive Total Rewards Plan, including:
Health & Welfare: Medical, dental, vision coverage for staff and eligible dependents
Financial Security: Retirement & Savings Plan with generous company contributions
Incentives: Discretionary annual bonus and long-term stock-based incentives
Time Off: Award-winning time-off programs and bi-annual company-wide shutdowns
Work Flexibility: Remote work arrangements and hybrid models where applicable
Career Development: Opportunities for continued learning, training, and growth
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
Accommodations available upon request for individuals with disabilities in the application and interview process.
Ready to Apply?
Visit: careers.amgen.com
Click “Apply Now” to submit your application for Job ID: R-223805.
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