北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京生物工程/生物制药招聘

Senior Biostatistician-高级统计师

昆泰企业管理(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-11-18
  • 工作地点:北京
  • 工作经验:招若干人
  • 学历要求:11-18发布
  • 语言要求:不限
  • 职位月薪:2.5-3万/月
  • 职位类别:生物工程/生物制药

职位描述



 

PURPOSE

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.

 RESPONSIBILITIES

? Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.

? Perform protocol development, sample size calculation, protocol and CRF review. ? Advise data management staff on database design, and critical data. May advise on validation checks. ? Write statistical sections of integrated reports. ? Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). ? Act as statistical team lead for single complex studies or groups of studies. ? Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements. ? Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. ? Manage customer relationships. ?

Provide training and guidance to lower level and new staff.


 REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

? Excellent written and oral communication skills including grammatical/technical writing skills

 ? Excellent attention and accuracy with details  ? In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials  ? Familiarity with moderately complex statistical methods that apply to applicable clinical trials  ? Strong individual initiative  ? Strong organizing skills  ? Strong working knowledge of SAS computing package  ? Familiarity with other relevant statistical computing packages such as nQuery  ? Strong commitment to quality  ? Ability to effectively manage multiple tasks and projects 


职能类别:生物工程/生物制药

公司介绍

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.

联系方式

  • Email:chinacampus@iqvia.com
  • 公司地址:地址:span建国门外大街光华东里8号中海广场