Plan, direct and coordinate a variety of specialized and complex global development projects; Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices; Provide scientifically rigorous statistical expertise on: Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; Regulatory and Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies
Requirements:
Advanced degree in statistics, biostatistics, or related field; A minimum of 7 to 8 years of experience in the clinical trial setting; Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations; Capability to provide statistical leadership to cross -functional teams at the protocol or project level; Strong statistical skills with application to clinical trials especially survival analysis methodology; Effective verbal and written communication skills
Text:
Director, Biostatistics - Internal Medicine & Hospital Products Plan, direct and coordinate a variety of specialized and complex global development projects; Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices; Provide scientifically rigorous statistical expertise on: Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; Regulatory and Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies Advanced degree in statistics, biostatistics, or related field; A minimum of 7 to 8 years of experience in the clinical trial setting; Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations; Capability to provide statistical leadership to cross -functional teams at the protocol or project level; Strong statistical skills with application to clinical trials especially survival analysis methodology; Effective verbal and written communication skills
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