长沙招聘

工作职责:

ROLE RESPONSIBILITIES

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

May have people management responsibilities

Will be a mentor to more junior colleagues

Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may contribute to under the leadership of the asset lead for lower complexity study and smaller submission. Ensures appropriate documentation across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate.

Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data

Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place.

Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may aid in development of standards necessary for their study

Will contribute to department level initiatives.

Proactive at communicating potential issues to upper management

Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations

任职资格:

QUALIFICATIONS

Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.

Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

At least 4 years sas/statistical programming experience.

Statistical Programming and SAS hands-on experience

Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.

Good understanding of ICH and Regulatory Guidelines

Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.

Thorough understanding of clinical data and relevant data standards

Extensive knowledge of routine statistical methodology and its application to programming

Demonstrated experience in developing successful partnerships within study teams

Good written and oral communication skills, and project management skills

Ability to present technical information to a non-technical audience

Proven ability to operate independently.

Ability to manage customer expectations.

CDISC experience highly desirable.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。