Statistical Programming Manager

3 weeks ago


Gurgaon, Haryana, India SUN PHARMA Full time

pbJobSummary/b/ppSunPharmaisseekingahighlyskilledbStatisticalProgrammingManager/btoleadourclinicaldataprogrammingteam.Asakeymemberofourteam,youwillberesponsibleforprovidingcomprehensiveprogrammingexpertisetosupportallclinicalstudiesandprojects./ppbKeyResponsibilities/b/pulliLeadstatisticalprogrammingactivitiesformultiplestudiesandprojectstoensuretimelyandhigh-qualityprogrammingdeliverables./liliDevelopandmaintainprogrammingdocumentationsfollowingprogrammingstandardsandprocesses./liliDevelopandoverseethedevelopmentofSASprogramsforthecreationofSDTMandADaMdatasetsfollowingCDISCstandardsandreports./liliContributetothedevelopmentofstandardmacrosandparticipateinestablishingandmaintainingstatisticalprogrammingstandards./liliParticipateintheCRFannotation,reviewofSAP,TLFsspecificationsdevelopmentandTLFsreview./liliHandleallP21relateditemsandeCRTpackageincludingaCRF,define.XML,cSDRG,ADRGandARMfortheregulatorysubmissiontoFDA/EMA/PMDAorotheragencies./liliSupportglobalregulatoryauthoritysubmissionsfollowingtheguidelines(sdTCG,DSC,eCTDetc.)andworkingcloselywithpartneringfunctionstoaddresshealthauthorityrequests./li/ulpbRequirements/b/pulliProficiencyinSASprogrammingskillsinaclinicaldataenvironmentwithexcellentanalyticalskills./liliGreatknowledgeofpharmaceuticalclinicaldevelopmentandregulatorysubmissions./liliAbilitytoworkindependentlyandonglobalinterdisciplinaryteams./liliProblemsolvingandinnovativeskillsthatdemonstrateinitiativeandmotivation./liliDemonstratedandappliedSASprogrammingskills./li/ulpbEducationandExperience/b/ppMinimumBachelor'sdegreeinStatistics,ComputerScience,Mathematics,Engineering,LifeScienceorrelateddisciplinewith8+yearsofprogrammingexperienceinprocessingclinicaltrialdatainthebiotechnology,pharmaceutical,CROorhealthcarerelatedindustry./p



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