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What Youll Do: Assist with the development and modification of department SOPs and work instructions Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians Develop study bids and changes in scope for Biostatistics
ESSENTIAL FUNCTIONS Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment Conduct protocol risk reviews and
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