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发表于 2011-3-13 21:46:03
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Position Purpose:
The Statistical Analyst assists during the development of data analysis plans in collaboration with statistical colleagues, physicians and/or medical colleagues. The Statistical Analyst is responsible for establishing analysis datasets and for analysing medical research data working with project statisticians and other study team members. This position description also encompasses activities performed at a Senior Statistical Analyst level.
Nature of Work:
The objectives listed below outline the scope of the position. The application of these objectives may vary, based upon current business needs.
Objective 1: Statistical Trial Analysis
• Collaborate with other statistical colleagues and study personnel to provide statistical input to statistical analysis plans.
• Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
• Accountable for developing requirements for reporting data set structure and content
• Accountable for programming or validation of programs to create reporting data sets and derived variables.
• Effectively justify methods selected and implement previously outlined analysis plans.
• Conduct peer review of work products from statistical colleagues.
• Effectively utilise current technologies and available tools for conducting the clinical trial analysis.
Objective 2: Data Integrity
• Collaborate with study working team to advise on data collection tools.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
Objective 3: Communication of Results and Inferences
• Collaborate with other statistical colleagues to write reports and communicate results.
• Responsible for assisting in the communication of study results via regulatory submission, manuscripts and other publications, as well as for communicating one-on-one with key customers.
• Assist or respond to statistical queries from other functional areas (e.g. medical, regulatory and marketing) working in collaboration with other statistical colleagues.
Objective 4: Process Improvements
• Responsible for developing and implementing innovative methods for improving the quality and efficiency of analysis and reporting techniques.
Objective 5: Therapeutic Area, SAS and Systems Knowledge
• Understand relevant disease states in order to enhance the level of customer focus and collaboration.
• Ensure replication of tools and systems, where applicable, and stay informed of technology advances.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Provide advice on current statistical packages and where required, research and implement alternative computing approaches to conduct specialised analyses.
• Provide training and advice to colleagues and external customers on statistical programming issues.
Objective 6: Regulatory Compliance
• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable corporate, medical, local and departmental policies, procedures, processes and training.
Essential Requirements
• Educated to at least BSc level in Statistics, Biostatistics, Computer Science or equivalent.
• Proficiency in the SAS programming language.
• Interpersonal/teamwork skills for effective interactions.
• Technical growth and application with working knowledge of statistics and statistical software.
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
• Creativity and Innovation.
• Demonstrated problem solving ability and attention to detail.
• Data analysis, technology and systems expertise.
Desirable Requirements
• Ability to successfully communicate statistical concepts to non-statisticians.
• Knowledge of the clinical trials process.
• Experience with biostatistical methods in clinical research.
• Experience in developing analysis plans from protocol design.
• Understanding of advanced statistical analysis for example, survival analysis, repeated measures mixed models, non-parametric regression.
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发表于 2011-3-10 13:14:28
发表于 2011-3-10 15:33:40