Associate Director of Biostatistics at Pfizer overseeing statistical analysis for Phase 1-3 studies. Collaborating on clinical study protocols and regulatory submissions while ensuring timely project deliverables.
Responsibilities
Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
Provide statistically sound experimental design and data analysis strategies to meet project objectives.
Provide statistical inputs on clinical development plans.
Contribute to the development of clinical study protocols and author statistical sections.
Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials.
Review and edit checks and participate in UAT of different systems.
Requirements
Ph.D. in Statistics, Biostatistics or related field with 5+ years of experience, or a master’s degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials.
High aptitude in FDA/EMA and other regulations.
High aptitude in ICH GCP guidelines.
High aptitude in Drug development process.
High aptitude in CDISC standards and implementation guides.
High aptitude in statistical methods and applications to clinical trial design and data analysis.
Programming skills in R and/or SAS.
Must demonstrate ability to develop and deliver multimode communications.
Experience in managing multiple projects.
Benefits
Health benefits to include medical, prescription drug, dental and vision coverage.
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