天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津生物工程/生物制药招聘

知名医药研发公司-Site Leader

北京科诺思通咨询有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:专业服务(咨询、人力资源、财会)

职位信息

  • 发布日期:2019-01-17
  • 工作地点:上海
  • 招聘人数:1人
  • 工作经验:无工作经验
  • 学历要求:招1人
  • 语言要求:不限
  • 职位月薪:40-70万/年
  • 职位类别:生物工程/生物制药

职位描述

Lead deliverable tasks in a timely, accurate, and efficient manner to ensure quality and productivity. These tasks may include, but are not limited, to the following:

1.       Lead study teams by participating in resource planning and managing timelines and deliverables. This includes managing programming assignments for project team members and following up on task status to ensure deliverables are completed on time and with quality.

2.       Prepare SDTM data mapping specifications, ADaM dataset specifications, data reviewer’s guides and define.xml documents. Perform QC review of these documents prepared by others.

3.       Program SDTM and ADaM datasets according to approved dataset specifications.

4.       Generate complete and accurate statistical tables, listings, and graphs (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats.

5.       Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements.

6.       Perform independent SAS programming validation of datasets and TLGs programmed by others.

7.       Perform 3rd level QC review and programmatic checks on programming deliverables before releasing them to clients.

8.       Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

9.       Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements.

10.    Actively contribute to the continuous improvement of clinical data standards, conventions and statistical programming SOPs. 

11.    Design and implement SAS macros to enable standardization and efficiency in statistical programming.

Qualifications and Experience:

  • A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least five years of relevant industry experience using SAS in clinical trial analysis and reporting.
  • A College English Test (CET) 6 certificate is highly preferred.
  • In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis.
  • Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies.
  • Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements.
  • Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies.
  • Strong leadership skills, commitment and drive to achieve goals.


公司介绍

CGP 020是全球***家全面整合多行业的线上线下人力资源综合平台。

成立于2012年的CGP,脱胎于传统的猎头公司,拥有近400名专业人士为跨国公司与本土企业提供猎头、招聘流程外包和派遣服务,目前已成为亚洲***的提供招聘解决方案的公司之一。

公司在中国大陆有14个办公室,并在中国香港,新加坡和美国都设有办公室。

在2018年,公司大力发展线上的拥有强大AI匹配技术的招聘平台,并获得了多个业内奖项,包括***招聘机构和具创新能力招聘机构。

Human Resources Asia Recruitment Awards 2018
- ***招聘机构 - 最终大奖
- 具创新能力招聘机构 - 金奖

RI Asia 2017-2018
- 最具潜力招聘服务商
- 中国***招聘服务商

Top HR 2018
- 最具发展潜力本土猎头机构大奖
- 中国猎头行业排行榜内资 TOP 3

联系方式

  • 公司地址:地址:span来福士办公楼11楼