Biostatistics Director – Oncology Biosimilars

Amgen

. Provide strategic statistical input for clinical development from early to late phase across multiple products and therapeutic areas .

Posted 10/15/2026full-timeRemote • United StatesLead💰 $200,109 - $270,735 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Biostatistics and statistical methodologies is essential for driving clinical development strategies and regulatory submissions. Proven leadership in managing statistical teams and fostering innovation in drug development processes is critical.

Highest-signal resume keywords

Biostatistics ExperienceStatistical Methodology ExpertiseRegulatory Submissions LeadershipAdaptive Design ExperienceTeam Development and Management

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Development PlanningStatistical ReportingStatistical Strategy DevelopmentStatistical MethodologiesDrug Development LifecycleBayesian Adaptive DesignGroup Sequential DesignTreatment Arm Selection AdaptationsStatistical Excellence

Soft Skills

Effective CommunicationPresentation SkillsMentorshipInnovation DriveCollaboration

Certifications & Qualifications

Doctorate Degree in BiostatisticsMaster’s Degree in BiostatisticsBachelor’s Degree in Biostatistics

Industry Keywords

Pharmaceutical IndustryMedical Research OrganizationsOncologyClinical TrialsRegulatory DocumentsCRO PartnershipsHealth-Authority CorrespondenceStatistical Opinion LeadersSOPsControlled Documents

Tech Stack

Tools & technologies

Flash

About the role

Key responsibilities & impact

Provide strategic statistical input for clinical development from early to late phase across multiple products and therapeutic areas
Develop and maintain statistical excellence in the design, analysis, and reporting of biosimilar development
Contribute to clinical development plans
Review clinical development plans, regulatory documents, study synopses, protocols, SAPs, flash memos, CSRs, submission documents, health-authority correspondence, and clinical publications
Hire, allocate, manage, and develop internal statistical staff
Develop and execute statistical strategies for clinical development programs
Ensure standards, technical quality, and consistent approaches in study design and statistical analysis
Provide statistical input into regulatory strategies, presentations, scientific reports, clinical trials, regulatory submissions, product defense, market support, and publications
Represent the statistical function in meetings with regulatory authorities, key opinion leaders, and specialist bodies
Provide oversight and mentorship to Amgen staff and CROs on study deliverables, timelines, and quality standards
Support development and review of policies, SOPs, and controlled documents
Provide subject matter expertise in statistical methodologies
Publish applied research and present statistical methodology at external scientific meetings
Stay current with scientific advances and update internal practices
Develop and maintain relationships with statistical opinion leaders in academia, regulatory agencies, and industry

Requirements

What you’ll need

Doctorate degree and 4 years of Biostatistics experience OR Master’s degree and 8 years of Biostatistics experience OR Bachelor’s degree and 10 years of Biostatistics experience
Master’s or Doctorate degree in Mathematics, Biostatistics or Statistics preferred
Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations
Deep knowledge of statistical methodology and applications within drug development, especially in oncology
Knowledge of statistical methodology and applications within drug development
Statistical leadership to regulatory submissions
Effective written and oral communication and presentation skills, including statistical strategy
Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs
Experience with adaptive designs, including group sequential design, treatment arm selection adaptations, Bayesian adaptive design, and/or combined phase 1/2 or phase 2/3 design
Life cycle drug development experience from pre-clinical development through clinical development and post-marketing
Demonstrated leadership attributes and a track record developing high-performance teams
Experience working within a global team and with CRO partners
Ability to work in the U.S. excluding Puerto Rico; sponsorship is not guaranteed

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
Career development opportunities
Financial plans with opportunities to save towards retirement or other goals
Work/life balance support