上海招聘

Responsibilities:

Basic Function:
The Statistician provides high quality statistical support to assigned Clinical Development studies. This includes protocol contributions, case report form definition, and scheduling of analyses Responsibilities range between conducting analyses to providing objective interpretation of results and defense of statistical decisions to clinical team. In addition (s)he ensures that the objectives, standards, deadlines and other requirements set by line management are attained.

Primary Responsibilities include:
Non drug development
· Assists in ensuring that statistical standards and SOPs are followed within the Section
· Assesses, recommends and develops new standards, policies and procedures.
· Keeps abreast of statistical methodological developments through literature and attendance at meetings. Obtains familiarity with regulatory authority guidelines relating to Biostatistics and with medical issues in own project areas
· Gets and maintains proficiency in in-house computer facilities and associated software
· Interacts with other departments, including Clinical Science, Regulatory Affairs, Project Management, etc.
· Assists in ensuring effective communications between staff
· Assesses, develops and documents new methods and software
· Participates in and contributes to internal training programs
· Develops and documents statistical programming standards in accordance with current statistical programming practices and regulatory authority requirements.
· Programs, validates and documents software in SAS following statistical programming standards and ensures its availability to users. Whenever creating new software, ensures the efficient use of existing software.

Drug development
· Provides high quality statistical support to clinical studies and projects, under the direction of more senior statisticians.
· Ensures that activities performed within a study or project are executed in a timely manner and to the required high statistical and reporting standards
· Responsible for the writing of the statistical section of the protocol, stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
· Writes statistical analysis plan. Ensures that statistical methods, programming algorithms, data presentations, output deliveries, and timing and load of work are sufficient detailed to execute the analysis smoothly
· Checks appropriateness of planned analysis. Assesses impact of subjects withdrawn/lost to follow-up and deviations from planned trial design. Checks validity of distribution assumptions and impact of outliers. Documents methods and procedures used in the analysis and decisions made about data handling
· Writes and assists in programming statistical outputs and their validation.
· Responsible for the statistical interpretation and the writing of statistical modules for the clinical study report.
· Ensures that members of drug development team, clinical team and management understand the interpretation of the statistical methods applied to the clinical study
· Ensures consistency within project and as far as possible between projects. Assists in the development and maintenance of project standards. Documents agreed Biostatistics policies and procedures
· Informs and makes recommendations to the project statistician on critical issues within the project.
· Participates, if necessary, in clinical team meetings, project team meetings, study management team meetings and investigator meetings as well as expert meetings and meetings with health authorities
· Participates in writing publications
· Maintains up-to-date project documentation including that of presentation, analysis and graphics software.
· Provides SAS datasets in the format required for special evaluations.
· Programs, validates and documents data tabulations, graphics and statistical evaluations for efficacy and safety. Ensures that programs developed for specific projects/protocols are sufficiently portable to allow application to other projects and protocols.

Requirements:

Relevant working experience: 1-3 years in Biostatistics and Clinical Trials

· Education: MSc (or equivalent) or PhD in Statistics or very similar area.

· Requirements on specific subject(s): Knowledge and experience in the use of statistical software (e.g., SAS) as well as knowledge of databases and interface systems; Communicates clearly and effectively in written reports, data presentations and meetings as required; Travel may be required.

· Language: Able to communicate clearly in both written and spoken English.

· Computer skill: Comfortable with Computers; can readily learn new software applications.

· Other skills and/or competence:

– Self-motivated and take initiative

– Establishes and maintains good working relationships; is co-operative. Takes cultural and value differences into account in dealings with others.

More Information related to This Position

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罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。