猎头发布：500强制药公司研发中心

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