Job Description - (Bio)statistician
Description
The (Bio)statistician provides statistical expertise to the clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the compound which is under development.
The (Bio)statistician supports all statistical activities in all phases of project related clinical development programme, and to play an active role in multi-disciplinary project and study teams.
Qualifications
A candidate for the position of (Bio)Statistician should possess a BA/BS in (Bio)statistics, or in a related subject with a high statistical content whereby further qualification in Medical Statistics is an advantage. The candidate should have working knowledge of statistical programs such as SAS and other Microsoft Windows applications and experience with the design and analysis of clinical trials is often preferred. Professional use of the English language; both written and oral.
Competencies
- Excellent verbal and written communication skills
- Shares knowledge
- Work precisely according to procedures, rules and regulations
- Approach issues from a number of perspectives, summarising data to draw a conclusion
Tasks
- Contribute to the development and maintenance in the (Bio)statistics group of methods and procedures based on Regulatory Guidelines and Company requirements
- Participate in Clinical Study Team meetings for assigned studies
- Responsible within the Clinical Study Team for the quality, accuracy and timely completion of assigned tasks
- Support any R&D department by providing statistical expertise for issues in preclinical and clinical research
- Responsible for making statistic model selection, experimental design, design and analysis of clinical trials
- Analyse and interpret data from individual trials
- Perform meta-analyses by pooling data from several studies
- Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format
- Co-operate in further development of internal guidelines and SOPs
- Prepare project summaries for weekly/monthly status meetings
- Update knowledge in statistical concepts, methods, and techniques
- Maintain state of the art statistical applications in clinical research
- Responsible for data processing for accurate relocation, formatting, generating and transmitting required data
- Prepare statistical contribution to Integrated Study Report
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