Principal Biostatistician

Role Summary

• Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
• Provide statistical expertise and contributions for projects and protocols in support of clinical development.
  
  

• Provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization 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.
• Accountable for study level statistical deliverables on assigned projects.
• Ensure that all study 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.
• Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.
• Participate in technical forums on statistical methodology and its applications pertinent to business needs.
• Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.
  
  

• Advanced degree (Masters, PhD) in Statistics, Biostatistics, or related field.
• 5-8 yrs. of relevant experience for master’s level, entry level Ph.D. as long as the Ph.D. research work is in a relevant area.
• Experience in clinical trials is necessary for Master’s degree, desirable for Ph.D.
• 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.
  
  

• Working knowledge of SAS, R
  
  

• Works with Data Sciences and Analytics (DSA) functional lines (Stats, AQDS and SDSA) and with different therapeutic areas.
• Works with statisticians and project teams in clinical development and medical affairs.