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更新于 3月17日

臨床試驗高級統(tǒng)計師/統(tǒng)計經(jīng)理(不限城市)

2.8-4萬
  • 廣州天河區(qū)
  • 5-10年
  • 碩士
  • 全職
  • 招3人

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  • 同事很nice
  • 工作環(huán)境好
  • 人際關(guān)系好
  • 團(tuán)隊執(zhí)行強(qiáng)
  • 交通便利

職位描述

臨床試驗臨床數(shù)據(jù)分析臨床前研究
CORE JOB TASK 1) Provide statistical input into the clinical development of drugs. 2) Assist in developing the technical details of client proposed documents. 3) Participate in clinical study design and protocol development as the role of project statistician. 4) Ensures that project-related biostatistics and programming work is carried out in a timely and compliant manner. 5) Establishes and maintains effective working relationships with study teams, including data management personnel, statistical programmers, clinical research and regulatory personnel and corporate partners. 6) Develop and review Statistical Analysis Plan (SAP) and TLF mock shells for clinical studies. 7) Conduct statistical analysis and CSR validation. 8) Conduct statistical programming validation. 9) Review critical statistical documents and analysis deliverables 10) Develop and review statistical reports development for clinical studies. 11) Participate in and review randomization schedule development. 12) Provide statistical support for IDMC and other disciplines related to biostatistics. 13) Provide input in the preparation of scientific presentations and manuscripts. 14) Act as statistical consultant to clients and study team in related disciplines. 15) Carry out all activities according to SOPs working within the framework of the Quality management System and to Good Clinical Practice (GCP) 16) Train and mentor junior biostatisticians. 17) Perform other duties as requested by management. 18) Participate in process improvement, training, standards development and enhancing statistical technical expertise. 19) Interviewing and selection of potential candidates 20) Provide ongoing training and mentoring within Statistical analyst and junior statistician to ensure thorough knowledge of the processes used and ongoing technical development. 21) Manage the statistician resource and provide necessary support to project team 22) Support business development activities. MINIMUM REQUIREMENTS 1) PhD in Statistics and related field with 3+ years’ experience 2) Master’s degree in Statistics and related field with5+ years’ experience in pharmaceutical industry 3) Good sense about statistical model 4) Excellent verbal and written communication skills, including formal presentation skills 5) Excellent analytical skills 6) Fluent in written and spoken English, CET6 is preferred 7) Hands on SAS skills in Base SAS, basic Macro programming and SAS/STAT. 8) Experience in development of SAS code or R code

工作地點

廣州天河區(qū)中泰國際廣場B座

職位發(fā)布者

郭女士/HR經(jīng)理

昨日活躍
立即溝通
公司Logo諾思格(北京)醫(yī)藥科技股份有限公司公司標(biāo)簽
諾思格(北京)醫(yī)藥科技股份有限公司是國內(nèi)專業(yè)領(lǐng)先,規(guī)模較大的臨床研究合同組織(CRO)之一,總部設(shè)在北京,辦事處設(shè)在上海、長沙、廣州、武漢、成都、西安、哈爾濱、南京、沈陽、天津、長春等省會城市;在國內(nèi)覆蓋60余個城市,在亞洲覆蓋6個國家與地區(qū),已與200余家機(jī)構(gòu),450余家醫(yī)院及600多個科室合作,目前已為260多位國內(nèi)外客戶提供國際標(biāo)準(zhǔn)的臨床研究外包服務(wù)。業(yè)務(wù)涵蓋新藥評估與咨詢、注冊事務(wù)、臨床試驗實施、數(shù)據(jù)管理和統(tǒng)計分析、醫(yī)學(xué)事務(wù)及培訓(xùn)等全方位服務(wù)?!皠?chuàng)新是我們的靈魂,執(zhí)行是我們的生命”詳情請登錄公司主頁: www.rg-pharma.com接收簡歷郵箱:hr@rg-pharma.com(郵件主題:城市+崗位名稱+本人姓名)【子公司】蘇州??漆t(yī)藥技術(shù)有限公司為諾思格(北京)醫(yī)藥科技股份有限公司的子公司,子公司成立于2015年01月14日,地址位于蘇州工業(yè)園區(qū)裕新路108號4樓,經(jīng)營范圍包括生物技術(shù)開發(fā)、生物檢測技術(shù)服務(wù)、會務(wù)服務(wù)。【子公司】南京艾科曼信息技術(shù)有限公司,專攻于臨床研究領(lǐng)域中的數(shù)據(jù)管理和統(tǒng)計分析環(huán)節(jié),全面移植美國CRO的質(zhì)量標(biāo)準(zhǔn)及管理體系,一步到位與國際CRO行業(yè)接軌。同時,服務(wù)質(zhì)量獲得歐美主要藥廠的認(rèn)證。自成立以來已完成300余項臨床項目,其中部分已經(jīng)獲得美國FDA及歐洲EMEA通過。率先使用國際標(biāo)準(zhǔn)數(shù)據(jù)管理系統(tǒng),所有高管均有在美國相關(guān)行業(yè)從業(yè)10年以上經(jīng)驗??偛课挥诒本?,在上海、南京、成都、武漢、合肥等省會設(shè)有辦公室。
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