Senior Manager, Biostatistics – Biosimilars

Amgen

Lead Biostatistics efforts for complex product studies at Amgen. Ensure statistical standards and strategies are met in clinical documentation and regulatory submissions.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $154,104 - $208,494 per yearWebsite

Tech Stack

Tools & technologies

Flash

About the role

Key responsibilities & impact

Join Amgen’s Mission of Serving Patients
lead a single large product, and/or more complex studies and/or projects
ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct
influences and contributes to the development strategy
defends statistical approaches internally and externally
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
Participates in the review of CRO Policies, SOPs and other controlled document development
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.

Requirements

What you’ll need

Doctorate degree and 2 years of Biostatistics experience OR Master’s degree and 6 years of Biostatistics experience OR Bachelor’s degree and 8 years of Biostatistics experience
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 Or 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.
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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

BiostatisticsStatistical Analysis Plans (SAPs)Statistical AnalysisStatistical methodologiesAdaptive designsGroup sequential designBayesian adaptive designClinical Study Reports (CSRs)Statistical contributions to regulatory submissionsProcess improvement

Soft Skills

LeadershipStrategic inputCommunication skillsCollaborationOperational excellenceDefending statistical findingsPresentation skillsInfluencingContributions to development strategyReviewing policies and SOPs

Certifications

Doctorate degreeMaster’s degreeBachelor’s degree