- Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
- Provide statistical expertise in maximizing the value of aggregate clinical data in support of scientific and drug development strategies.
- Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.
- Provide statistical expertise and contributions for projects and protocols in support of clinical development.
- 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.
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
- Provide statistical input to cross-functional activities – collaborate with other statisticians, study managers, and other colleagues – for assigned studies and regulatory submissions
- Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
- Provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects
- Accountable for study level and submission level statistical deliverables on assigned projects.
Qualification & Experience:
- Advanced degree in statistics, biostatistics, or related field.
- Capability to provide statistical leadership to cross -functional teams at the protocol level.