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Pfizer Inc. Director Biostatistics in Denver, Colorado

ROLE SUMMARYThe successful candidate must plan, direct and coordinate a variety ofspecialized and complex research projects within Vaccines Medical, must haveknowledge of clinical design of experiments, clinical data management andprogramming tools, and ability to interpret results from clinical andepidemiological studies. Successful candidate also participates in regulatorysubmissions and response to regulatory queries. The candidate directlycontributes to company success by increasing the strength of study designs,interpretability of results, regulatory strategy & interactions,biomarker strategies and by implementing appropriate statistical methods ofenhanced quantitative vaccine development and real world research studies.This includes resource allocation, directing the scheduling of workassignments, and monitoring project status to assure timely completion ofprojeThis position is for the personal to work as the Vaccine asset statisticallead, serve as the voting member of MSC and other governance committee toreview CDI vaccine research proposals Serve as the study level statisticianfor studies, outpatient study within the asset responsible, Serve as thestudy level statistician for other asset, working the asset statisticallead, Contributor of the statistical function training material foron-boarding new statisticians Co-authorship of manuscripts for peer reviewedpublications.ROLE RESPONSIBILITIESProvide scientifically rigorous statistical input into regulatory strategy,medical development plans, epidemiology plans, protocol development,regulatory submissions and questions, interpretation of statisticalresults, study design, statistical analysis plans, business developmentopportunities and other product support projects.Be accountable for study level and statistical deliverables on assignedprojects, including timeliness and quality of deliverables according toproject plans.Provide statistical input and leadership to cross-functional activities underappropriate business models - collaborate with other statisticians, studymanagers, Vaccines colleagues - for assigned studies and regulatorysubmissions, including allocation of resources to provide services in linewith company priorities, and monitoring progress towards timely completionof services.Ensure that all study and project level statistical activities are conductedin compliance with relevant regulatory requirements and Pfizer standards.Contribute to the high-level decision making for Vaccine assets with respectto entire patient population decisions, label changes, dosing decisions,and individual study designs.Provide planning, delivery and communication of statistical analyses, datapresentations, and scientific reports, including clinical trial results,exploratory and meta-analysis results, support and authorship forpublication activities, scientific presentations, and support to productdefensIdentify opportunities to utilize innovative statistical methodology tofacilitate optimal decision-making.Participate in research on statistical methodology and its applicationspertinent to the Pfizer business needsBe up to date on SOP training and compliance with all Pfizer SOPs as requiredbased on the assigned curriculumComply with all statistics and quality processes and Pfizer data standardsthat are applicable to statistical outputs, and support processes thatrequire statistical input.Communicate and collaborate with other project statisticians within Pfizer toensure consistency of statistical approaches across studies and alignment withapproaches used in epidemiological studies and regulatory submissions.Help maintain a strong statistics community at Pfizer throughcollaborations, scholarship, presentations and learnings across divisionsand locations.Provide input to the Senior Director of Statistics to plan support forassigned studies and vaccine asset lead effort.Train new statisticians in Translational ResearchQUALIFICATIONSEffective verbal and written communication skills in