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默沙东(中国)投资有限公司

10 上海 | 500-1000人

五险一金包吃周末双休

生物统计师,后期研发统计组 ¥20000-30000

-北京- | 全职 |学历不限 |应届毕业生 | 性别不限 | 2人 申请职位

详细介绍

Brief Description of Position:

- Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.

- Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

The incumbent may initially work in a specific disease therapeutic area.

Primary activities:

- Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.

- Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.

- Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.

- Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.

- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.

- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.

- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

- Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.

- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

- Involved in research activities for innovative statistical methods and applications in clinical trial development


Qualifications, Skills & Experience:

PhD or equivalent degree in statistics/biostatistics or related discipline, or a master’s degree

Required Skills and Experience:

- Knowledge of statistical analysis methodologies and experimental design.

- Working knowledge of statistical and data processing software e.g. SAS and/or R.

- Good oral and written communication skills. Able to work effectively with personnel with different functional background.

- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.

- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

An understanding of biology of disease and drug discovery and development.


You can expect:

- Continuous learning and development including the best training programs on each stage of your career

- Multi-culture, dynamic environment

- Continuous growth through professional coaches

- Good environment and be inspired to do your best work for our patients and consumers.


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