Dear AllSTAT,
Statistician with ADaM Statistical Experience.
An exciting opportunity to work for one of our clients projects providing support to a major Pharmaceutical Company.
The role is home based or office based in the U.S.
Key Skills / Knowledge:
• In depth knowledge/experience of data collection and reporting in drug development and clinical trials process
• Design of ADaM datasets to support complex endpoint analysis
• Experience with a variety of study designs, TA's, and analysis methods
• Experience of implementing ADaM data standards in a practical setting
• ADaM-IG v1.0 practical knowledge
• ADaM v2.1 practical knowledge
• Aptitude for data standards and data standardization
• Excellent verbal and written communication skills
• A detailed understanding of the metadata requirements for analysis results and for ADaM datasets. Experience in Define-XML version 2 would be an advantage
• Collaborating in global cross-functional team
• Knowledge of computer programming, preferably SAS or other statistical languages such as R
Qualifications:
Masters or PhD in Statistics / Biostatistics
5+ years knowledge/experience in Pharmaceutical / Biotech industry
Demonstrated effective communication skills (written and oral)
5 years work experience in Data Management, Biostatistics or Programming in the Pharmaceutical or Biotech arena
Consultants should have practical experience implementing ADaM and the ability to assist the study teams to create analysis dataset specifications that conform to the ADaM standard (e.g. define dataset, variable, value and results level metadata) and have a strong background in statistics.
For further details, please contact me directly at [log in to unmask]
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