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本帖最后由 kingsoild3505 于 2011-12-5 15:33 编辑
Position: Clinical Statistician
Zone / Line: Medicine Development Group, Primary Care Business Unit
Department: Statistics, Pfizer China Research & Development Center (CRDC)
Career Ladder: D2/D3
Location: Zhangjiang, Shanghai
Position Purpose:
• Design, Analyze, and Interpret Clinical Trials
• Provide statistical expertise and contributions for projects and protocols in support of Clinical development.
• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.
• Provide statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies.
• Provide study level statistical leadership and communicate resource needs to management and other line functions for the execution of statistical tasks.
Organizational Relationships:
• Reports to the local Site Head, Statistics
• Matrixed relationship with other members of study team: Clinicians, Clinical Pharmacology, Clinical Programming & Writing (CPW), Study Manager, Protocol leads, and Project Leads in Regulatory.
Qualifications and Responsibilities:
Qualifications:
• Advanced degree in statistics, biostatistics, or related field. Experience in clinical trials is desired 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.
Responsibilities:
• Through effective partnership with lead project statistician, provide statistical input to study design, 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, CPW 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.
Prior Experience Preferred
• Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
Competency:
• All vary with Career Ladder level with increasing competence expected at more senior grades and with greater emphasis on assessment of potential at more junior grades
• Able to provide timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions
• Strong analytic skills, well-organised, clearly documents what has been done, is aware of and adheres to relevant SOPs
• Able to manage complex projects and cross-functional processes
• Familiar with and comfortable using deployed technologies and tools; identifies new opportunities and emergent needs and acts on them
• Strong presentation and communication skills working with colleagues at Dev sites; able to effectively communicate technical material to non-technical audience; proactively proposes new ideas and able to refine ideas of others
• Excellent written English and communication
• Strongly focused on identifying and understanding the needs of key customers and ensuring productive working relationships
• Able to work effectively in a multi-cultural and diverse business environment spanning international borders and time zones
• Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage
• Able to work effectively within a complex organization to influence key stakeholders
• Looks for opportunities for collaboration and acts upon them
统计学相关专业，博士优先，有海外学习或者项目经验者更佳,薪资待遇优厚
联系方式：TEL:13917297754
Mail:kingsoild3505@126.com |
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发表于 2011-12-5 15:28:57
