Clinical Biostatistician

Function

Provide input to protocol development/sample size calculation & protocol/CRF review
Prepare randomization schema
Develop analysis plans
Perform data review & statistical analyses
Co-ordinate and produce tables, listings & figures
Perform independent QC
Write statistical sections for integrated reports
Advise DM with respect to database design, validation checks & key data
Maintain professional statistical standards
Maintain & archive program documentation - both electronic & paper - in an appropriate manner
Understand regulatory statistical guidelines/developments
Project Responsibility & Customer Interaction
Attend customer meetings to discuss project requirements/progress
Perform Statistical Team Leader role for single study projects

Master's degree or educational equivalent in biostatistics or related field and 3 to 5 years relevant experience
Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
Strong working knowledge of SAS computing package, CDISC Standards, familiarity with other statistical computing packages
Pharmaceutical, drug development, biotech or CRO industry experience
Strong written and oral communication skills in English, strong attention and accuracy with details, strong initiative, organization skills and multi-tasking ability, ability to lead and co-ordinate small teams

Woluwe-Saint-Lambert

Baltazar

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