Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs; Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis; Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs); Providing input for clinical publications and regulatory filing documents; Leading all aspects of work performed by study statisticians; Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations; Anticipating and communicating resource and quality challenges that could impact results or timelines
Requirements:
Doctorate degree in biostatics or statistics; 7 or more years of pharma/biotech statistical experience; Life cycle drug development experience (pre-clinical, clinical and post-marketing); Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
Text:
Biostatistics Associate Director Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs; Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis; Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs); Providing input for clinical publications and regulatory filing documents; Leading all aspects of work performed by study statisticians; Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations; Anticipating and communicating resource and quality challenges that could impact results or timelines Doctorate degree in biostatics or statistics; 7 or more years of pharma/biotech statistical experience; Life cycle drug development experience (pre-clinical, clinical and post-marketing); Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
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