Associate Director, Biostatistics

ROLE SUMMARYDesign, 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.Provide study and other project level statistical counsel and communicate resource needs to teams.ROLE RESPONSIBILITIESProvide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.Develop effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory, payer, industry, professional and academic organizations.Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.Maintain compliance with all required training.Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions.Provide input to Statistics Program Lead and/or Statistics Therapeutic Area Head to plan support for assigned projects, studies, and submissions.Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.Communicate and collaborate with other project statisticians, or other organizations where applicable, to ensure consistency of statistical approaches across studies and alignment with approaches used in regulatory submissions.Present a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.BASIC QUALIFICATIONSAdvanced degree in statistics, biostatistics, or related field.A minimum of 4 years’ experience in the clinical trial setting (preferably in oncology of Pharma).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 level.Strong statistical skills with application to clinical trials especially survival analysis methodology.Effective verbal and written communication skills.Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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