(Senior) Principal Biostatistician
Boehringer IngelheimShanghaiUpdate time: September 6,2019
Job Description
(Senior) Principal Biostatistician-199773
Talent@Boehringer Ingelheim
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
- Act as project/trial statistician responsible for multiple (more than three) clinical trials up to the highest complexity within national or international development projects or for marketed products as required. The responsibilities cover, for example, writing the statistical section of the clinical trial protocol, reviewing case report forms, specifying the randomization scheme, presenting critical statistical aspects at investigators meetings, preparing the trial statistical analysis plan (TSAP) and interpreting the analysis results, participating in the writing of the clinical trial report and of publications thereof;
- Collaborate with other scientists of Clinical Development, Medical Affairs and Translational Medicine in planning complex clinical trials, conforming to company and regulatory guidelines. Collaborate with other scientists including marketing and market access in planning of results publications;
- Act as project statistician, or support other project statisticians to play, specify, supervise and verify the entire analysis of data from mutliple complex clinical trials.
- Participate in the writing of the integrated summary documents for world-wide submissions and of publications;
- Promote efficient, innovative and robust drug development processes, with emphasis on the analysis and reporting of clinical data, e.g. by particpating in international working groups or by acting as a team leader for complex analysis projects;
- Representing the company at meetings with regulaotry authorities, clincial investigators, reimbursement agencies etc. on statistical aspects of his/her pivotal trials
Qualifications
- Education/Degree Requirements: Master of Science or PhD
- Major: Biostatistics or Statistics
- Language skills & proficiency: English and Mandarin Chinese, fluent in speaking, reading and writing
- Required capabilities (skills, experience, competencies):
-PhD or Master of Science with at least 5 years’ experience as statistician in international pharmaceutical development or regulatory agency or at an academic institution in the area of clinical research; Sound knowledge of statistical methodology to critique devised hypotheses and results interpretation; -Ability to communicate statistical information to non-statisticians; Excellent oral and written communication skills
工作 - 注册/ 法规
主要地点 - Africa, Asia, Australasia-CN-上海-上海
组织 - 勃林格殷格翰（中国）投资有限公司
编制 - 全职
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