- Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
- Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables under the supervision of senior statistical staff.
- Provide study level statistical expertise and communicate resource needs to management and other line functions for the execution of statistical tasks.
- Provide statistical expertise in maximizing the value of aggregate clinical data in support of scientific and drug development strategies under the supervision of senior statistical staff.
- Provide statistical expertise and contributions for projects and protocols in support of clinical development under the supervision of senior statistical staff.
- Provide statistical input to cross-functional activities – collaborate with other statisticians, study managers, and other colleagues for assigned studies and regulatory submissions
- Develop effective collaborations and sound working relationships with others within GPD
- Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
- Provide input to management plans to support assigned studies and submissions.
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
- Accountable for study level and submission level statistical deliverables on assigned projects.
Qualification & Experience:
- Strong statistical skills with application to clinical trials.
- Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.
- Advanced degree (Masters, Ph.D.) in Statistics, Biostatistics, or related field.
- Experience in clinical trials is desirable but not necessary.