Senior Biostatistician I

  • 面議(經常性薪資4萬/月含以上)

  • 2年以上工作經驗

  • 碩士以上

  • 台北市 信義區 松仁路

更新日:2020/11/25


工作內容

Job Overview:  

 

Provides biostatistical services to meet the requirements of all Clinipace’ s clients, including full-service, Global Clinical Analytics (GCA), and other type studies. This may include but it’s not limited to: development and approval of Statistical Analysis Plans and table shells, randomization schemes, review of data management documentation, lead development of Protocols and approve the statistical section in Clinical Study Reports, serve as Quality Control Biostatistician or IDMC statistician. The Senior Biostatistician I will act independently for most projects. 

 

Job Duties and Responsibilities: 

 

Meets all the job duties, responsibilities, and requirements of a Biostatistician in addition to those listed here. 

 

Coordinate and approve Statistical Analysis Plans (SAP), table shells, programming and derived dataset specifications developed by Biostatistics and Statistical Programming staff. 

Lead protocol development work including experimental design, randomization, sample size calculation, statistical methods, defining study objectives and parameters. 

Coordinate and approve the statistical section of the Clinical Study Report (CSR) written by Biostatistics staff and collaborate with Medical Writer in preparing the integrated CSR as needed. 

Coordinate and approve TFL and derived datasets, programming of derived datasets and Tables, Figures and Listings (TFL), and data review and statistical analysis developed by Biostatistics and Statistical Programming staff. 

Provide management of other Biostatistics Department requirements and functions, such as SOP updates, as requested by line manager. 

Serve as Quality Control Biostatistician for sample size calculation reports. 

Serve as IDMC / DSMB statistician as needed. 

Other duties commensurate with the position as assigned by line manager. 

Provide staff training and study oversight as requested by line manager. 

Provide staff oversight as mutually agreed with line manager. 

 

More Information: https://cho.tbe.taleo.net/cho01/ats/careers/requisition.jsp?org=CLINIPACE&cws=1&rid=5037

發展願景

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. With personalized services and solutions, local regulatory expertise and therapeutic leadership, we overcome the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, nephrology and urology, rare disease, and women’s health. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach.

成就樂趣

丘以思生技(Clinipace, Formerly Choice Pharma)為美商公司,專精臨床試驗,在業界擁有優良商譽。待遇福利佳,除享勞保,健保,員工團體保險,車資補助,員工意外險,生育、婚喪補助金外,並有優秀的工作團隊及完整的教育訓練。在休假方面,除週休二日外,並有彈性工作時間、遠優於勞基法的年休假制度。是一個可以學習成長、獲取工作成就感的溫暖大家庭。

工作制度/性質

工作地點:
台北市 信義區 松仁路101號10樓A,D,E室    [地圖]
工作時間:
日班 說明:依公規定
休假制度:
週休二日
工作待遇:
面議(經常性薪資4萬/月含以上)    [$薪資公秤]
工作福利:
[同公司福利]
公司福利 ×

法定項目
勞保、健保、週休二日、陪產假、育嬰假、生理假、特別休假、員工體檢、勞退提撥金

福利制度
獎 金 類:年終獎金
保 險 類:員工團保
餐 飲 類:伙食津貼
娛 樂 類:國內旅遊、國外旅遊、春酒、下午茶、家庭日
丘以思生技(Clinipace, Formerly Choice Pharma)為美商公司,專精臨床試驗,在業界擁有優良商譽。待遇福利佳,除享勞保,健保,員工團體保險,車資補助,員工意外險,生育、婚喪補助金外,並有優秀的工作團隊及完整的教育訓練。在休假方面,除週休二日外,並有彈性工作時間、遠優於勞基法的年休假制度。是一個可以學習成長、獲取工作成就感的溫暖大家庭。


工作性質:
全職
職務類別:
統計精算人員 數學研究人員 病理藥理研究人員

要求條件

身份類別:
不拘
工作經驗:
2年以上工作經驗
學歷限制:
碩士以上
科系限制:
數學統計學門 數理統計學類 應用數學學類 其他數學及統計學類 生命科學學門 醫藥衛生學門

語言能力:
英文 聽-精通 | 說-精通 | 讀-精通 | 寫-精通
電腦專長:
Word Excel PowerPoint Outlook SPSS SAS lnternet Explorer MS SQL Oracle

附加條件:

Job Requirements: 

 

Education 

PhD or Master’s in statistics or related area, or equivalent degree globally 

Experience 

PhD + 3-5 years (or MS + 5-7 years) experience in pharmaceutical, CRO, or related environment. 

Skills/Competencies 

Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results. 

Ability to develop professional presentations for presenting statistical issues and solutions to clients internally. 

Ability to effectively learn and handle new or unfamiliar statistical methods. 

Ability to find needed written resources and interact with other Biostat staff with the needed familiarity.  

Willingness to share expertise with younger staff members. 

Capabilities 

Excellent broad ranging understanding of statistical methods and issues.  

Has a developed expertise in 1-2 therapeutic areas. 

Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team. 

Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts. 

Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics. 

Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies. 

Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget. 

Excellent training and presentation skills: Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations. 

Strong understanding of departmental and company procedures which relate to tasks that are performed routinely: Strong understanding of all departmental SOPs and good understanding of all required company SOPs.  

Familiarity with Clinipace Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas. 

Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc.

profile
聯絡人員:
HR

需求人數:
1人
到職日期:
不限

面試地址:
郵寄地址:
傳真號碼:

電子信箱:

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