Manager, Statistics

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.

• 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.

• 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.

Reports to Statistics Group Lead or Head, Statistics

• Varies with…