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Head of Exploratory Biostatistics Group
4 months ago
AccountabilitiesProvides leadership to the Exploratory Biostatistics Group (EBG) of CfDASets vision, mission and strategy of the EBGAdvises 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 makingProvides 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 LeadershipProvides holistic vision for EBG to align exploratory statistical analysis activities with Dev TA and Precision Medicine organization prioritiesThrough 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 initiativesContributes to CfDA organizational strategy as part of extended leadership teamEngages 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 developmentServes as primary CfDA liaison to collaborate with GDL/EDL/GSL/biomarker and CDx lead for clinical trial biomarker exploratory analysis needsEstablishes and maintains a strong network of statistical experts in exploratory analysis of biomarker data or subgroups across industry, regulatory, academia and internal SMEsBuilds strategic partnership and collaboration with Development and Precision Medicine cross-functional teams
Leads and Develops Exploratory Biostatistics Group Team & MembersRecruits, coaches, develops and retains multiple functions within the EBGManages budget and resources
Authority Deployment of appropriate resources across the pipeline for the EBGDecisions related to biomarker exploratory analysis and interpretation impacting program strategyFinal review of biomarker analysis plan and analysis result presentations to EGTs or governance committeesBudget input and financial sign-off as dictated by GCF level Decisions affecting development of staff within the EBG and staff recruitment to the EGBOrganizational structure and operational strategy of the EGBFunctional oversight and sign-off for contracts with external partners
Qualifications
Basic Qualifications
Doctorate degree and 5 years of experience ORMasters degree and 9 years ofexperience ORBachelor's Degree and 11 years of experienceIn 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 leadershipExtensive experience interacting with translational medicine and early development teams Deep Understanding of biomarker data and its application to clinical researchFamiliar with and active interest in emerging trends on use of innovative approaches in biomarker-informed drug development and drug/CDx co-developmentScientific research / publications in one or more areas of statistical and therapeutical sciencesExpertise in multiple therapeutic areasWell 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 expendituresExperience developing policies and SOPsCompetenciesScientific / Technical Excellence Broad and deep expertise in statistical principles, methods, and procedures and the ability to provide guidance to staff statisticiansBroad and deep expertise in disease population, biomarker subgroups, exploratory analysis and how they can inform drug developmentScientific 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 responsibilityStrong network with KOLs in the industry, regulatory, and academic communitiesStrong oral and written communication skillsStrong influencing and negotiating skillsExcellent business acumen and strategic thinkingStrong partnership with cross-functional senior leaders to ensure business strategies are carried out throughout the development programsPeople / Project ManagementExcellent communication skills to interface with senior leadership on behalf of the departmentExcellent collaborator with leaders across functions (Precision Medicine, Dev TA, GBS in CfDA, and other related functions) Well-recognized leader internally and externallyStrong team builder who can attract, coach, grow and retain staff
