长沙招聘

职位描述：
Responsibilities:
? Through effective partnership with lead project statistician, provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects
? Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.
? Accountable for study level and submission level statistical deliverables on assigned projects.
? Develop effective collaborations with others within Clinical R&D (clinicians and pharmacokineticists), and external regulatory, industry, professional and academic organizations.
? Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
? Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, and other colleagues – for assigned studies and regulatory submissions
? Provide input to management plans to support assigned studies and submissions.
? Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
? Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.
? Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches
? Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
? Participate in research on statistical methodology and its applications pertinent to business needs.

Technical Competencies:
Competency
Regulatory expertise
Scientific/administrative excellence
Project/process management
Systems Technologies
Presentation/influencing skills
Written communications skills

Behavioral Competencies:
Competency
Customer focused
Cultural awareness
Innovation
Influencing
Networking and Alliance Building

Qualifications (Training, Education & Prior Experience):
? Advanced degree in statistics, biostatistics, or related field.
? Experience in clinical trials is desirable but not necessary.
? Capability to provide statistical leadership to cross -functional teams at the protocol level.
? Strong statistical skills with application to clinical trials.
? Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.

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。