天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津医药技术研发管理人员招聘

Biostatistician / Sr. Biostatistician

方达医药技术(上海)有限公司

  • 公司规模:150-500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:2012-08-08
  • 工作地点:北京-东城区
  • 招聘人数:1
  • 工作经验:三年以上
  • 学历要求:硕士
  • 语言要求:英语
  • 职位类别:医药技术研发管理人员  

职位描述

Position Summary:
Frontage is seeking enthusiastic Biostatistician / Senior Biostatistician to join our China Biometric operation in Shanghai or Beijing office. Incumbent will develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members or project sponsors regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports.

Major Responsibilities:
1 Able to provide statistical consulting independently and prepare statistical sections of protocols
2 Perform sample size and power calculation for studies
3 Create randomization schedule per study design and relevant specifications
4 Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
5 Develop statistical analysis plans (SAP) independently and prepare analysis data specifications
6 Able to develop SAS programs to develop statistical models and complete statistical analyses
7 Develop or validate SAS programs to create derived variables and analysis data sets
8 Perform senior review of analysis data and TLGs
9 Prepare statistical reports
10 Review and provide input and interpretation of analysis result to support clinical study report (CSR)

Qualifications:
1 Advanced degree (MS or PhD, or equivalent) in Biostatistics or closely related field
2 3-5 years direct advance knowledge of clinical trials design and analysis experience with advanced SAS programming experience in contract research organization (CRO) environment
3 Working knowledge of CDISC standards and application of those standards to projects
4 Ability to effectively communicate with others on the project team and with project sponsors.
5 Ability to work on several projects simultaneously
6 Demonstrated knowledge of design of clinical trials and regulatory requirements
7 Knowledge of design of clinical trials and regulatory requirements
8 Excellent English communication skills (verbal, written & interpersonal)

公司介绍

方达医药全球型全方位新药研发外包服务公司(CRO),于2001年成立于美国,总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术(上海)有限公司,在苏州和郑州分别设有分公司和管理团队。2019年5月30日,方达控股(方达医药上市主体)成功登陆香港联交所主板,股票代码*******。

方达医药始终坚持“中美两国,同一质量体系”准则,获得数据可用于全球申报,目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴,方达医药拥有技术熟练的专业团队,配备了国际最先进的药物研发仪器和设备,并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务,业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。

● 我们为员工提供全面的福利待遇,并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会,让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会,确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产,我们拥有明确的员工奖赏计划,肯定员工的奉献精神,奖励员工的辛勤付出。

您也可以发送简历至招聘邮箱:recruitment@frontagelab.com.cn
更多信息请浏览公司网站:**********************

联系方式

  • Email:recruitment@frontagelab.com.cn
  • 公司地址:地址:spanhomebase