Associate Director, Biostatistics

ROLE SUMMARY + 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. + Provide study and other project level statistical counsel and communicate resource needs to teams. ROLE RESPONSIBILITIES + Provide 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 QUALIFICATIONS + Advanced 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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