Strategic Oncology Biostatistics TA Leader

Amgen; United States; Hybrid; USD 267,000 - 362,000; Full time

Benefits offered by this job

Retirement and Savings Plan with gener

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a Biostatistics Oncology Therapeutic Area Head to define enterprise-level strategy for biostatistics in Oncology, representing the function at the highest levels and driving innovation and transformation across teams.

The role requires deep statistical leadership, cross-functional collaboration, and global stakeholder engagement, with a focus on regulatory science and patient-centric drug development. Competitive benefits and flexible work options accompany the position.

Qualifications

• Doctorate degree & 6 years of biostatistics oncology experience OR
• Master’s degree & 10 years of biostatistics oncology experience OR
• Bachelor’s degree & 12 years of biostatistics oncology experience AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Responsibilities

• Sets and leads the biostatistical strategy and technical expertise for Oncology TA, including opportunities for innovation and continuous improvement
• Advises and collaborates with cross-functional TA Heads, including related analytical groups, across Amgen regarding statistical strategies that impact drug development and regulatory/HTA/medical strategies
• Identifies and implements new pragmatic methodologies aimed at improving drug development strategy, regulatory science, and patient centricity
• Provide statistical consultancy, training, and advice within Amgen
• Drive and contribute to the development of Amgen Policies, SOPs and other controlled biostatistics documents
• Implement and manage standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis for designated TAs
• Influence Amgen’s statistical priorities internally and externally via KOL relationships, publications, presentations, and through key partnerships as appropriate
• Provide oversight for Key Design Elements (KDE), protocols, Statistical Analysis Plans (SAPs), Flash Memos/Summary of Report (SoR), Clinical Study Reports (CSRs), publications, and contribute to regulatory documents in various development stages, reimbursement documents and other communications for TAs
• Partners with functional leaders across Amgen and with external stakeholders
• Contributes to CfDA organizational strategy as part of leadership team; serves as a primary representative for Oncology TA at Amgen-wide committees and meetings
• Engages and aligns staff with Amgen priorities, including identifying and championing impactful and innovative opportunities for Oncology TA
• Leads decisions regarding statistical differences of opinion (e.g., statistical methodologies) within Oncology TA
• Manages technical and good practice oversight within Oncology TA
• Provide statistical strategy on signal detection capabilities for use in the analysis of pre-marketing and post-marketing adverse event databases, and on life-cycle safety-related activities for a product

Skills

Leadership

Strategic thinking

Communication skills

Regulatory knowledge

Education

Doctorate degree in Statistics/Biostatistics or related subject

Master’s degree in Statistics/Biostatistics or related subject

Bachelor’s degree

Job description

Amgen seeks a Biostatistics Oncology Therapeutic Area Head to define enterprise-level strategy for biostatistics in Oncology, representing the function at the highest levels and driving innovation and transformation across teams.

The role requires deep statistical leadership, cross-functional collaboration, and global stakeholder engagement, with a focus on regulatory science and patient-centric drug development. Competitive benefits and flexible work options accompany the position.