POSITION?SUMMARY?職位概要
Clinical?Programmers?in?the?Clinical?Programming?and?Writing?(CPW)?Group?of?China?R&D?Center?(CRDC)?provide?clinical?programming?support?for?various?Pfizer?global?and?regional?clinical?studies.?They?work?closely?with?statisticians?to?implement?analyses?as?specified?in?statistical?analysis?plans,?table?shells,?and?programming?requirement?documents.?They?are?responsible?for?extracting?data?from?databases?to?produce?tables,?graphs,?analyses,?and?data?listings?based?on?clinical?data,?either?for?regulatory?submission?and?reporting?purposes?for?new?drug?application?or?for?marketing?support.?They?may?also?provide?input?and?review?for?the?activities?of?other?statistics?and?clinical?programming?personnel,?e.g.?the?review?of?Case?Report?Forms,?protocols,?statistical?analysis?plans,?table?shells,?programming?requirement?documents,?and?databases?in?the?future.??Clinical?programmers?work?primarily?in?the?SAS?programming?language,?and?follow?standardized?quality?control?procedures?for?the?development,?testing?(including?peer?review),?and?implementation?of?their?programs.?They?work?closely?with?colleagues?in?the?Report?Publishing?Group?to?coordinate?inclusion?of?components?into?clinical?study?reports.
臨床數(shù)據(jù)程序員服務(wù)于輝瑞中國研發(fā)中心臨床數(shù)據(jù)程序及報(bào)告撰寫部，為輝瑞全球和各地區(qū)的臨床研究項(xiàng)目提供數(shù)據(jù)分析編程支持。臨床數(shù)據(jù)程序員與統(tǒng)計(jì)人員密切合作,?根據(jù)統(tǒng)計(jì)分析計(jì)劃﹑報(bào)表模版及程序要求文件進(jìn)行分析。臨床數(shù)據(jù)程序員負(fù)責(zé)提取數(shù)據(jù)庫數(shù)據(jù)以生成報(bào)表﹑圖表﹑分析和臨床數(shù)據(jù)列表，為新藥注冊(cè)報(bào)批申請(qǐng)和市場(chǎng)活動(dòng)提供支持。同時(shí)，該職位將來可能對(duì)其他統(tǒng)計(jì)或臨床數(shù)據(jù)程序人員的工作提供建議和檢查，如：病歷報(bào)告表格﹑臨床試驗(yàn)方案﹑統(tǒng)計(jì)分析計(jì)劃﹑報(bào)表模版﹑編程要求文件及數(shù)據(jù)庫進(jìn)行檢查。臨床數(shù)據(jù)程序員主要運(yùn)用SAS語言進(jìn)行編程，并遵循標(biāo)準(zhǔn)質(zhì)量控制流程進(jìn)行程序開發(fā)﹑測(cè)試（包括第二者程序檢查）及程序運(yùn)行。臨床數(shù)據(jù)程序員將與臨床報(bào)告編輯部門緊密合作，負(fù)責(zé)協(xié)調(diào)將編程產(chǎn)生的結(jié)果整合進(jìn)入臨床試驗(yàn)報(bào)告。
POSITION?DETAILS
Reports?to: Manager?of?Wuhan?CPW,?CRDC
臨床數(shù)據(jù)及報(bào)告撰寫部經(jīng)理(武漢)，中國研發(fā)中心
Department: CPW,?WRDC
臨床數(shù)據(jù)及報(bào)告撰寫部(武漢),?中國研發(fā)中心
Location: Wuhan
KEY?RESULT?AREAS
? Perform?activities?and?provide?technical?expertise?in?support?of?reporting?data?from?clinical?trials.
? Design?and?plan?statistical?algorithms?and?code?in?conformance?with?a?globally?aligned?Systems?Development?Life?Cycle?(SDLC)?and?programming?standards?and?within?the?applicable?regulatory?guidelines?for?the?assigned?clinical?development?programs?for?worldwide?filings.
? Ensure?that?all?programs,?outputs?and?documentation?are?consistent?with?relevant?ICH?(eg.?E6,?E9,?E10?etc)?requirements?and?are?conducted?in?compliance?with?relevant?SOPs.
? Be?accountable?for?implementation?of?statistical?analyses,?programmed?outputs,?and?tables?listings?and?graphs?for?integrated?scientific?reports?for?clinical?trial?results?and?support?for?publication?activities,?for?assigned?projects.
? Provide?input?into?the?design?and?development?of?project?plans;?in?providing?planning,?development?and?delivery?of?analyses,?(tables,?listings?and?graphs),?for?use?in?scientific?reports,?clinical?trial?results,?publications,?regulatory?response?and?commercialization.
? Implement?global?strategies,?initiatives,?processes,?and?standards?to?ensure?speed?and?quality?of?fully?integrated?global?data?analyses?on?individual?studies,?submissions?and?other?reporting?of?aggregated?data.
? Ensure?clear?and?timely?communication?with?colleagues?to?enable?improvements?to?be?implemented?during?the?study?and?also
? Liaise?regularly?with?manager?or?other?business?owner?to?assess?workload?and?priority?activities?and?status?of?assigned?tasks?and?projects.
? Ensure?timely?delivery?of?outputs?to?meet?study?timelines?and?quality?expectations
? Work?with?manager?or?other?CRDC?management?(if?necessary)?to?give?input?to?project?plans?and?to?implement?resource?strategies?to?achieve?CRDC?goals.
? Provide?regular?feedback?as?to?the?efficiency?and?effectiveness?of?current?procedures/jobs?to?manager.
Personal?Development:
? Attend?and?actively?participate?in?personal?development?courses?as?required.
? Attend?Pfizer?in?house?training?and?workshops.
? Develop?and?maintain?competence?in?SAS?programming?and?other?related?tools.
ESSENTIAL?REQUIREMENTS
Education學(xué)歷要求
? At?least?bachelor?degree?or?equivalent?in?statistics,?computer?science,?or?a?mathematical?science
統(tǒng)計(jì)學(xué),計(jì)算機(jī)或數(shù)學(xué)相關(guān)領(lǐng)域大學(xué)本科及以上
? Master's?Degree?preferred
碩士學(xué)位優(yōu)先考慮
Experience經(jīng)驗(yàn)要求
? 3?years?relevant?experience?with?SAS?programming?in?clinical?development
具備三年臨床研發(fā)領(lǐng)域的SAS編程經(jīng)驗(yàn)
? Some?clinical?development?and?business?experience?in?order?to?have?an?understanding?of?the?processes?associated?with?clinical?and?regulatory?operations.
有臨床開發(fā)與藥品業(yè)務(wù)方面經(jīng)驗(yàn)，了解臨床和新藥開發(fā)的相關(guān)程序。
? Experience?supporting?regulatory?submissions
具備協(xié)助新藥申報(bào)的工作經(jīng)驗(yàn)
? Extensive?knowledge?of?computer?systems,?operating?systems?and?analysis?and?reporting?environments?used?in?the?support?of?clinical?programs?and?the?development?of?software?via?structured?SDLC.
擁有廣泛的電腦系統(tǒng)﹑操作系統(tǒng)和用于支持臨床項(xiàng)目的分析報(bào)告環(huán)境以及通過SDLC進(jìn)行軟件開發(fā)等方面的知識(shí)。
Key?Competencies技能要求
? Strong?understanding?of?the?current?technologies?and?global?Analysis?and?Reporting?environments?to?utilize?them?for?efficient?delivery?of?programming?outputs.
熟悉醫(yī)藥科技現(xiàn)狀和全球數(shù)據(jù)分析及報(bào)告系統(tǒng)，以有效的進(jìn)行數(shù)據(jù)編程。
? Expertise?in?the?SAS?programming?language.
精通SAS編程語言
? Effective?verbal?and?written?communication?skills?in?relating?to?colleagues?and?associates?both?inside?and?outside?the?organization
? 具備對(duì)內(nèi)/對(duì)外及同事間有效的口頭和書面溝通技巧
? Basic?knowledge?to?use?Windows?OS,?MS-Word,?MS-Excel,?E-Mail?(MS-Outlook).
能夠運(yùn)用視窗操作系統(tǒng)，Word,?Excel,?Outlook
? Ability?to?write?clear,?well?documented,?and?standardized?computer?programs.
能夠編寫清晰標(biāo)準(zhǔn)，文檔完整的計(jì)算機(jī)程序
? A?readiness?and?ability?to?work?to?pre-defined?programming?standards.
具備按已定義的編程標(biāo)準(zhǔn)進(jìn)行工作的能力
? Strong?analytical?skills.
具備很強(qiáng)的分析能力
? Able?to?work?on?multiple?projects?simultaneously.
具備同時(shí)進(jìn)行多個(gè)項(xiàng)目工作的能力
? Demonstrated?platform?skills.?Experience?in?presenting?to?science?and?non-science?audiences.
具備良好的基礎(chǔ)能力，擁有面對(duì)學(xué)術(shù)和非學(xué)術(shù)聽眾的演講經(jīng)驗(yàn)
? Demonstrated?effective?written?communication?skills
良好的書寫能力進(jìn)行有效的演示
? Capability?to?communicate?effectively?in?English,?both?verbally?and?written.
能夠熟練運(yùn)用英語進(jìn)行書面和口頭的有效溝通
? May?oversee?contractors
可能對(duì)外包服務(wù)進(jìn)行監(jiān)督
? Must?be?accurate?and?have?an?excellent?attention?to?detail?and?a?quality?control?approach?to?work.
必備高度精確性，非常關(guān)注細(xì)節(jié)，及質(zhì)量控制的工作方式
? Ability?to?work?effectively?in?a?multi-cultural?context
能夠在多文化氛圍下高效工作
? Ability?to?work?effectively?in?a?matrix?organization
能夠在矩陣組織中工作
? Utilizes?and?shares?innovative?approaches?to?build?and?maintain?a?competitive?advantage
利用并分享創(chuàng)新的方案來建立和保持競(jìng)爭(zhēng)優(yōu)勢(shì)
? Looks?for?opportunities?for?collaboration?and?acts?upon?them
主動(dòng)尋找合作機(jī)會(huì)并采取相應(yīng)行動(dòng)
? Respectfully?challenges?practices,?decisions?or?ideas?to?uphold?integrity?and?ethical?standards.
以尊重的態(tài)度來挑戰(zhàn)日常實(shí)踐操作和決定以保證完整性和符合規(guī)范
? Contributes?to?a?learning?organization,?encouraging?experimentation,?risk-taking,?and?development?in?all?aspects?of?work?performance.
愿意為一個(gè)學(xué)習(xí)型組織工作，鼓勵(lì)進(jìn)行嘗試，承擔(dān)風(fēng)險(xiǎn)，并在工作績效的各方面尋求進(jìn)步