Sr. DM Programmer（Outsourced to Top10 Pharma）社

面议

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

Requirement：
1.Shouldhasaround4–6yearexperienceofSAS
2.HavetheexperienceonthelogiccheckfromDMendbyusingSAS
3.Englishskill:couldcommunicateforthedailyworkinginEnglish
4.SDTMknowledge,mediumSDTMknowledge,easytounderstandthedatastructureinSDTMformat

Trialactivities:
?PrepareannotatedCRFs/e-CRFsasnecessary
?Develop,validate,document,andmaintainsoftwarerequiredtoconductorsupportdatamanagementrelatedactivitiesprimarilyinthecontextofclinicaltrials,projectsorprograms,suchasprogramsfordataextractsfromOracletoSASdatasets,DQSP’s,PatientProfiles,requiredreportsorlistingsorfigures,creationofdefine.xmlandconversionprogramstoSDTM(includingmodificationsduringTrialConduct),ifapplicableandundersupervisionofLineManagement,performsurveillanceofabovementionedprogrammingactivitieswhenconductedbyin-sourcedstafforstaffworkinginoff-shores
?ProvideinputintoCRFspecifications,datatransferspecifications,databasedesign,andquerycheckspecificationsthroughreviewofprotocol,CRF,thedatamanagementplan,datamanagementreport,datavalidationplan,anddataqualitysurveillanceplan,whateverisapplicable
?RunDQSPs,editchecks,reportsorlistingsanddataextractsonclinicaldataaccordingtotimelinescommunicatedbytheTrialDataManagerifneeded
?PerformelectronicdataloadsintoOracle,downloadsfromOracletoSASdatasetsandstoreSASdatasets(includingCROdeliverables)intheappropriatestoragelocationintheSASenvironment
?Providerelevantdocumentationanddataforarchiving
?Assign/restrictaccessrightstoclinicaltrialdatabases
?Lock/unlockdatabasesasrequested


B.Nontrialactivities:
oSystemmaintenance/enhancementsandprocessimprovements
?Contributetothecontinuousimprovement,re-engineeringandimplementationofprocesses,tools,technologies,conventions,standards,policies,StandardOperatingProcedures(SOPs),andWorkingInstructions(WIs)asneeded
?Developandmodifyeditchecksasneededforthestandardgloballibrary
?Create,validateandmaintaingloballyre-usableprograms/macrosthatstreamlinerepetitiveoperations
?Programadministrativereportsasneededforclinicaltrials
?InterfacewithSAStechnicalsupporttoresolvesoftwareproblems
?Communicatetechnicalprogrammingconceptsinaclear,conciseandfocusedmanner.
?UnderthesupervisionofLineManagement,plan,communicate,andimplementthesurveillanceoftheprogrammingactivitiesperformedbyaContractResearchOrganizations,in-sourcedstafforstaffworkinginoff-shores
?Developexperienceandskillsinnewsystemswhennecessary
oTraining–Providing
?MentormorejuniorAPDsinallaspectsoftheGCDSprocess
?Train/giveguidancetoGCDSstaffontheuseoftheapplications(existingandnewones)
?AssistwithtrainingofAPDs/in-sourcedstaff/staffworkinginoff-shores
oTraining–Receiving
?Keepuptodatewithjobrelatedtopics,inparticularwithregardtoSASandSQL
?BeuptodatewithSOPs,WIs,andusermanualsandmaintaintraininglog


EDUCATION/LANGUAGES
Basic,BachelororMasterofScience(preferablyinanumeratedisciplinesuchasStatistics,ComputerScience,orMathematics)degreeinhealthrelatedfieldand/orcomputerscienceorequivalent
ExcellentknowledgeofEnglish(FrenchorGermanisaplus)


PROFESSIONALSKILLS&EXPERIENCE
Experienceinclinicaldatamanagement/statistics/statisticalprogramminginthepharmaceutical/biotechnologyindustry,equivalentto-4years
ExpertiseinSAS/BASE,SAS/Macro,SQL(knowledgeofotherSASmodulesisaplus)
KnowledgeofOracle,WebbasedEDC,HTML,XML,VBSCRIPTisaplus
KnowledgeofCDISCingeneralandcomprehensionofSDTManddefine.xml(ADaMisaplus)
Knowledgeofregulationsandguidanceswithregardtoclinicaldevelopment,thesystemsusedinthiscontextanddatamanagementrelatedaspectsofe-submissions


PERSONALSKILLS&COMPETENCIES
Excellentwritten,verbalandorganizationskills
Abilitytohandlemultipleprojects
Excellentteamplayer,workseffectivelyininternationalteams,andmulti-disciplinarygroups.
Excellentaccuracyandattentiontodetail
Abilitytounderstandcustomerrequirementsandconvertthemintorealizablepackages.
Potentialtodevelopsolutionsandoptimizeprocesses.
Well-organized,high-qualitytargeted.
Mentoringandtrainingskills.

其他要求

招聘人数：1人
职能类别：数据库建设

公司介绍

昆拓信诚医药研发（北京）有限公司是昆泰公司投资全资子公司，为美资CRO公司，依托昆泰公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以昆泰为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。
应聘邮箱：hr01@kuntuo.com请将简历直接贴在正文中，勿带附件发送，谢谢。