Senior Biostatistics Manager, Biosimilars

Lifelancer

Biostatistics Senior Manager leading statistical contributions and strategy for biosimilars development in the pharmaceutical industry. Collaborating with teams and managing complex studies and projects.

Posted 7/7/2026full-timeRemote • District of Columbia, Washington • 🇺🇸 United StatesSenior💰 $NaN per yearWebsite

Tech Stack

Tools & technologies

Flash

About the role

Key responsibilities & impact

Lead a single large product, and/or more complex studies and/or projects
Ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct
Influence and contribute to the development strategy, and defend statistical approaches internally and externally
Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Plan and execute 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
Provide statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents
Oversee statistical work performed by CROs in a full-service CRO model
Perform statistical analysis of multiple studies/projects and subsequent exploratory analyses, and make sound conclusions and recommendations
Represent the Biostatistics function and participate in multidisciplinary project team meetings; collaborate closely with other functional team members; incorporate knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provide support and input in case report form design, and data collection)
Proactively anticipate and communicate 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
Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings
Participate in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO’s process maps; contribute to process improvement and operational efficiency
Adhere 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. 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

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
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

Statistical AnalysisStudy DesignStatistical MethodologiesData CollectionStatistical Documentation

Soft Skills

Effective CommunicationLeadershipCollaborationStrategic InputProblem Solving