Amgen · 1 day ago
Biostatistics Associate Director
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
5+ years expAmgen is a biotechnology company dedicated to improving the quality of life for people around the world. They are seeking a Senior Manager of Biostatistics in Biosimilar Development to independently lead large products and complex studies, ensuring statistical standards and contributing to development strategies.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Plans and executes statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model
Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents
Oversees statistical work performed by CROs in a full-service CRO model
Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations
Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection)
Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally
Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice on biosimilar development
Stays abreast of latest developments in the field of statistics in drug development and contributes to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings
Participates in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO’s process maps; contributes to process improvement and operational efficiency
Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development
Qualification
Required
Doctorate degree and 3 years of biostats experience OR Master's degree and 5 years of biostats experience OR Bachelor's degree and 7 years of biostats experience OR Associate's degree and 12 years of biostats experience OR High school diploma / GED and 14 years of biostats experience
Preferred
Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Knowledge/experience of biosimilars development, non-inferiority or equivalence trials
Statistical contributions to regulatory submissions
Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design
Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
Demonstrated ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
Demonstrated effective communication skills (written and oral)
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
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