Director

• Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of complex programs
• Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with Strategic Development Director, Director, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical Leads
• Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support
• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
• Partner with CfDA Design & Innovation to drive novel designs and fit-for-purpose statistical approaches, standards, technical quality, study design, analysis, interpretation and evidence synthesis in balance with speed, quality, and cost for designated products / programs
• Partner with Strategic Development Director / Director, Statistical Innovation / EDL / GDL / GMAL / PT to define the data and evidence requirements for product lifecycle and translate it into the EGP as well as other potential applications of innovations (e.g., collaborations with CfOR and HEOR)
• Oversee creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP
• Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listings shells, submission data file specifications, and other key product-related documentation
• Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support for HTAs and payer negotiations, regulatory submissions RTQs, safety and benefit-risk assessment, and scientific publications
• Provide strategic input and be the key biostatistics contact for regulatory queries and interactions with regulatory agencies in collaboration with the Principal Statistician
• Contribute to statistical strategy with other analytical groups (e.g. PK/PD modelling strategy, biomarker analysis plan)
• Lead global biostatistics team
• Lead in the achievement of annual department goals
• Manage and develop staff
• Ensure Biostatistics team effectively utilize assigned supplier resources
• Oversee development of Amgen Policies, SOPs and other controlled documents

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