
Senior Statistical Programmer

職位描述
職位描述:
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might
act as an internal subject matter expert in specific areas providing technical support and expert advice,
and works independently to support various programming activities related to the analysis and
reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical
Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other
functional areas as required.
Key Accountabilities
??Deliver best value and high quality service
??Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
Coordinator will:
o Input into and negotiate statistical programming timelines. Ensure that timelines are
adhered to.
o Coordinate and lead a statistical programming team to successful completion of a study
within given timelines and budget
o Monitor project resourcing, project budgets, and identify changes in scope
??Interact with Sponsors as the key contact with regard to statistical programming issues
??Provide technical support and advice to the internal team
??Check own work in an ongoing way to ensure first-time quality
??Ensure quality control (QC) on all process and technical activities related to derived dataset, table,
listing, and figure programming in accordance with corporate quality standards,
WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
Skills
??Proficiency in SAS
??Knowledge of the programming and reporting process
??Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other
applicable local and international regulations such as 21 CFR Part 11 and proven practical
application
??Demonstrate ability to learn new systems and function in an evolving technical environment.
??Strong leadership ability
??Attention to detail
??Ability to successfully work together with a (“virtual”) team (including international teams as
required) as well as independently
??Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to
change
??Business/Operational skills that include customer focus, commitment to quality management and
problem solving
??Good business awareness/business development skills (including financial awareness)
企業(yè)簡介
公司簡介:
國際精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系協(xié)助世界各國大藥廠從事新藥開發(fā)及臨床試驗(yàn)的臨床研究委托機(jī)構(gòu)(Contract Research Organization)。
國際精鼎臨床試驗(yàn)研究團(tuán)隊(duì)是由一群具有豐富跨國性臨床試驗(yàn)經(jīng)驗(yàn)及專業(yè)知識(shí)的精英所組成,目前已成為亞洲地區(qū)規(guī)模最大、服務(wù)項(xiàng)目最完整之專業(yè)CRO公司,幷已在業(yè)界建立高品質(zhì)的專業(yè)形象以及良好口碑。
APEX目前擁有超過300名的專業(yè)精英,服務(wù)遍及11個(gè)國家,在CRO的領(lǐng)域里已是亞洲的領(lǐng)導(dǎo)先驅(qū)。預(yù)計(jì)2007年APEX服務(wù)版圖將再擴(kuò)及2個(gè)國家、4個(gè)服務(wù)據(jù)點(diǎn),人員也將擴(kuò)增至500人。APEX重視與客戶的承諾,更重視人才的培育和養(yǎng)成,我們提供完整的教育訓(xùn)練、職涯規(guī)劃、優(yōu)于市場的薪資福利、良好工作環(huán)境,期許同仁與公司一同成長,邁向未來。
主要服務(wù)項(xiàng)目:
? 新藥開發(fā)策略的擬定與計(jì)劃
? 國際臨床試驗(yàn)規(guī)劃及整合
? 引薦、甄選試驗(yàn)計(jì)劃主持人
? 受試者同意書之設(shè)計(jì)
? 人體試驗(yàn)委員會(huì)之送審
? 最高衛(wèi)生主管機(jī)關(guān)之送審
? 臨床試驗(yàn)護(hù)理專員
? 臨床研究數(shù)據(jù)處理
? 向亞洲地區(qū)衛(wèi)生主管機(jī)關(guān)辦理新藥查驗(yàn)登記事務(wù)
? 中草藥及健康食品臨床試驗(yàn)、法規(guī)咨詢及查驗(yàn)登記
愿景(Vision):創(chuàng)造一個(gè)在亞太地區(qū)具有國際競爭力的最精良CRO團(tuán)隊(duì)。
發(fā)展使命(Mission):
1 爭取國際大藥廠委托,執(zhí)行符合國際水準(zhǔn)的跨國性臨床試驗(yàn)。
2 協(xié)助亞太生技及制藥產(chǎn)業(yè)建立新藥開發(fā)模式,以提升產(chǎn)品研發(fā)能力,幷促使產(chǎn)品國際化。
3 以提升臨床試驗(yàn)品質(zhì)為宗旨,拓展全球市場為目標(biāo),整合計(jì)算機(jī)及通訊科技,在國際上提供客戶兼具成本效益及效率的臨床試驗(yàn)數(shù)據(jù)處理中心。
4 建立一個(gè)以亞洲人種高發(fā)生率疾病的基因數(shù)據(jù)庫,以提供國際性新藥研發(fā)機(jī)構(gòu)所須之基因信息,協(xié)助其縮短藥物開發(fā)時(shí)程,幷提高研發(fā)成功率。
福利制度:
.薪資:
1. 提供具競爭性之薪資(含車補(bǔ)及飯補(bǔ))
.保險(xiǎn)類:
1. 社會(huì)保險(xiǎn)(依照國家規(guī)定)及住房公積金
2. 團(tuán)體保險(xiǎn)(包括壽險(xiǎn)、意外暨醫(yī)療保險(xiǎn))
.制度類:
1. 學(xué)習(xí)發(fā)展計(jì)劃 (Learning & Development): 針對(duì)個(gè)別員工之專業(yè)及興趣,設(shè)計(jì)符合其個(gè)人之生涯規(guī)劃
2. 完整的教育訓(xùn)練:每年公司均針對(duì)所有員工,提供完整之教育訓(xùn)練
3. 順暢的升遷管道及可轉(zhuǎn)調(diào)其它部門;如有職缺,亦可申請(qǐng)調(diào)至海外各子公司
.請(qǐng) / 休假制度:
1. 服務(wù)第一年即享有9天特休, 后續(xù)年休假天數(shù)則依據(jù)服務(wù)年資及公司制度而定
2. 一年可享4天不扣薪病假
職位發(fā)布企業(yè)
精鼎醫(yī)藥研究開發(fā)(上海)有限公司
企業(yè)性質(zhì):民營企業(yè)
企業(yè)規(guī)模:50-99人
成立年份:1996
企業(yè)網(wǎng)址:www.apex-cro.com
企業(yè)地址:浦東新區(qū)
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職位發(fā)布日期: 2016-12-09

