寻找R&D（研发中心）和医学部的海归人才，包括研发中心的scientist、药品上市前临床试验的physician、生物统计师（statistician）、临床试验项目经理(PM)、临床监察员（CRA），以及医学部的医学顾问（MA），医学联络官（MSL）等等
Job Posting
招 聘 通 知
Position: Clinical Statistician
Zone / Line: Medicine Development Group, Primary Care Business Unit
Department: Statistics, 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
发表于 2011-12-29 11:07:08
