Biostatistics Oncology TA Head

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

Basic Qualifications

• Doctorate degree & 6 years of biostats oncology experience OR Master’s degree & 10 years of biostats oncology experience OR Bachelor’s degree & 12 years of biostats 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

Preferred Qualifications

• Experience developing policies and SOPs
• International collaboration and experience working globally
• Scientific research / publications in one or more areas of statistical science
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Life Cycle Drug Development Experience (e.g. global product lead statistician experiences)
• Excellent oral and written English communication skills
• Thorough understanding of regulatory and industry trends in standards and their implementation
• Established records of strong leadership and people management skills
• Prior regulatory and reimbursement submission experience, including advisory committees
• Doctorate in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research including related Oncology TA experience
• Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 16 years of post-graduate statistical experience in the pharmaceutical industry or medical research including related Oncology TA experience