Description
**Accountabilities**
•Provides leadership to the Exploratory Biostatistics Group (EBG) of CfDA
•Sets vision, mission and strategy of the EBG
•Advises and collaborates with the Precision Medicine network (inc. Dev TA heads, GDL/EDL, GSL, Pre-clinical biomaker and CBD biomarker and CDx leads) regarding biomarker exploratory analysis for evidence generation and product strategy
•Sets and drives strategic application of exploratory analysis of RUO (Research Use Only)/IUO (Investigation Use Only), CTA (Clinical Trial Assay) and CDx biomarker data in clinical trials to inform drug development decision making
•Provides statistical, strategic, data-informed decision making to cross-functional teams
•Drives statistical innovation with Head of D&I and the rest of CfDA leadership
•Strategic partner and collaborator with senior leaders cross other development and translational medicine functions within Amgen (Precision Medicine, Dev TA, GBS, CBD, Precision Medicine)
**Responsibilities**
**Strategic** **and Technical** **Leadership**
•Provides holistic vision for EBG to align exploratory statistical analysis activities with Dev TA and Precision Medicine organization priorities
•Through collaboration with Precision Medicine, Dev TA, CfDA and other related functions, builds industry-leading capabilities in the application of exploratory statistical analysis methods of biomarker and subgroups to support drug development strategy and execution
•Drives applications of proper exploratory statistical methods on biomarker data and subgroups to inform and support drug development strategy and execution
•Drives collaboration of quantitative functions to provide EGTs with insights from biomarker exploratory analysis on key development questions
•Contributes to Amgen development transformation through collaboration and advice internal initiatives
•Contributes to CfDA organizational strategy as part of extended leadership team
•Engages and aligns staff with Amgen priorities
**Builds Partnerships**
•Serves as an internal and external face of CfDA for driving proper exploratory analysis of clinical trial biomarker data or subgroups for evidence generation and biomarker-informed drug development
•Serves as primary CfDA liaison to collaborate with GDL/EDL/GSL/biomarker and CDx lead for clinical trial biomarker exploratory analysis needs
•Establishes and maintains a strong network of statistical experts in exploratory analysis of biomarker data or subgroups across industry, regulatory, academia and internal SMEs
•Builds strategic partnership and collaboration with Development and Precision Medicine cross-functional teams
**Leads and Develops Exploratory Biostatistics Group Team** **&** **Members**
•Recruits, coaches, develops and retains multiple functions within the EBG
•Manages budget and resources
**Authority**
•Deployment of appropriate resources across the pipeline for the EBG
•Decisions related to biomarker exploratory analysis and interpretation impacting program strategy
•Final review of biomarker analysis plan and analysis result presentations to EGTs or governance committees
•Budget input and financial sign-off as dictated by GCF level
•Decisions affecting development of staff within the EBG and staff recruitment to the EGB
•Organizational structure and operational strategy of the EGB
•Functional oversight and sign-off for contracts with external partners
**Qualifications**
**Basic Qualifications**
+ Doctorate degree and 5 years of experience OR
+ Master’s degree and 9 years ofexperience OR
+ Bachelor’s Degree and 11 years of experience In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.Your managerial experience may run concurrently with the required technical experience referenced above
**Preferred Qualifications**
•Life cycle drug development experience and strategic leadership
•Extensive experience interacting with translational medicine and early development teams
•Deep Understanding of biomarker data and its application to clinical research
•Familiar with and active interest in emerging trends on use of innovative approaches in biomarker-informed drug development and drug/CDx co-development
•Scientific research / publications in one or more areas of statistical and therapeutical sciences
•Expertise in multiple therapeutic areas
•Well recognized strategic and technical leadership internally and externally
•Track record of successful project and people management (6+ years)
•Experience managing budget and resource planning and expenditures
•Experience developing policies and SOPs
**Competencies**
**Scientific / Technical Excellence**
•Broad and deep expertise in statistical principles, methods, and procedures and the ability to provide guidance to staff statisticians
•Broad and deep expertise in disease population, biomarker subgroups, exploratory analysis and how they can inform drug development
•Scientific leadership in the biopharmaceutical industry and within Amgen to advance biomarker exploratory analysis in evidence generation and influence translational medicine and early development teams in areas of responsibility
•Strong network with KOLs in the industry, regulatory, and academic communities
**Strong oral and written communication skills**
**Strong influencing and negotiating skills**
**Excellent business acumen and strategic thinking**
•Strong partnership with cross-functional senior leaders to ensure business strategies are carried out throughout the development programs
**People / Project Management**
•Excellent communication skills to interface with senior leadership on behalf of the department
•Excellent collaborator with leaders across functions (Precision Medicine, Dev TA, GBS in CfDA, and other related functions)
•Well-recognized leader internally and externally
•Strong team builder who can attract, coach, grow and retain staff
