Job at a glance
JOB 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: o Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; o Regulatory and Health Technology Assessment (HTA) submissions; and o 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. JOB 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 study or project level and submission level statistical deliverables on assigned projects. ? Accountable for implementation of quality, productivity, and other best practices. ? 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 to Statistics Group Lead and/or Head, Statistics input for planning support for assigned projects, studies, and submissions.
? Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects. ? 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 within R&D, 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.
QUALIFICATIONS/SKILLS ? Advanced degree in statistics, biostatistics, or related field. ? 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 and/or analysis of observational studies.
? Effective verbal and written communication skills. ORGANIZATIONAL RELATIONSHIPS ? Reports to Statistics Group Lead or Head, Statistics RESOURCES MANAGED ? Varies with career ladder level and project need-Statistics Leads may supervise the work of other statisticians. ? No direct budgetary responsibilities. The closing deadline for applications