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AbbVie Director, Statistics in North Chicago, Illinois

Director, Statistics

USA, Illinois, Lake County

Research & Development

Requisition #1906357

P u r pose

TheDirector,Statisticsprovidesscientificandstatisticalleadershipforassignedclinicaldevelopmentprojects.Ahighlyempowered,visibleandcollaborativerole,theDirectorworksinpartnershipwithclinicalandregulatoryexpertstoadvancemedicinestoourpatients.

M a j or Job Re s p on s i b i li ti e s:

  • Leadthestatisticalsupportforoneormoreclinicaldevelopmentprojectsthroughowneffortsorthoseofateam.Leadstatisticalstrategyforprojectdevelopmentandregulatorysubmission.

  • Directandreviewthedevelopmentofdesign,analysisandreportingforclinicalorotherscientificresearch programs.Reviewprotocols,statisticalanalysisplans,andstatisticalprogrammingplans.

  • Representfunction/departmentonprojectteam(s)toprovidestatisticalinputtocompound/drugdevelopment anddrivealignmentwithfunctionalmanagement.Partnerwithotherfunctions(Clinical,Regulatory,PatientSafety,orGMA)tocreatedevelopmentstrategiesforassignedprojects.RepresentDSSondatamonitoringcommittees.Buildinterdepartmentalrelationships.

  • Demonstrateextensiveunderstandingofstatisticalconceptsandmethodology.Proposenovelstatisticalmethodologicalapproachestodesignofscientificstudies.Providesufficientdetailtoallowprogramming implementation.Ensurethatallstatisticalanalysesspecifiedinscientificprotocolsandanalysisplansareconductedappropriately.

  • Leadstrategyanddirectdevelopmentandimplementationofproject-specificdatabase-relatedactivitiesincollaborationwithDataSciences,StatisticalProgrammingandotherstakeholders.

  • Trainandmentorstaffonstatisticalmethodologyandoperations.Maysuperviseagroupofstatisticiansasa peoplemanager.Gainexpertiseininnovativestatisticalmethods.Assistfunctionalleadersinrecruitingqualified personnelandarrangingtrainingopportunitiesforprofessionaldevelopmentofstaff.

  • Developstrategyfordatapresentationandinference.Ensureappropriateinterpretationofstatistical deliverablesincollaborationwithotherfunctions.Collaborateinpublicationofscientificresearch.Ensure accuracyandinternalconsistencyofreportsandpublications,includingtables,listings,andfigures.

  • ActastheliaisonforstatisticalissuesonAbbViecollaborativestudieswithCROs,academicinstitutions,governmentagencies,steeringand/ordatamonitoringcommittees,jointventuresorlicensingactivities.BuildexternalscientificconnectionswhichfosterprofessionaldevelopmentandpromotethereputationoftheStatisticsdepartment.

  • Ensurethatallapplicableregulatoryrequirementsforworkprocessesaremet.Criticallyreviewregulatorysubmissiondocuments.RepresentDSSindiscussionswithregulatoryagenciesandonAdvisoryCommittees.

  • Developanexternalpresencewithinthestatisticscommunityandrepresent Abbvieonadvancedandemerging topics.

Level will be based on education & years of experience.

Educational Requirements:

  • MS (with a minimum of 12 years of experience) or PhD (with a minimum of 8 years of experience) in Statistics, Biostatistics, or highly related field

  • At least 12 years (MS) or 8 years (PhD) of experience in pharmaceutical development required.

Educational Requirements (preferred):

  • MS (with a minimum of 14 years of experience) or PhD (with a minimum of 10 years of experience) in Statistics, Biostatistics, or a highly related field.

  • At least 14 years (MS) or 10 years (PhD) of experience in pharmaceutical development required.

Additional Requirements:

  • High degree of technical competence and excellent communication skills, both oral and written

  • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others

  • Able to build strong relationship with peers and cross-functional partners to achieve higher performance.

  • Highly motivated to drive innovation by raising the bar and challenging the status quo

  • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams

  • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.

  • For people mangers, prior experience of people management is required

Additional Information

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time

  • Job Level Code: M

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