Principal Statistician - FSP

Primary Responsibilities & Expectations:

• Provide statistical expertise for experimental design, descriptive and inferential statistics, and analysis and reporting of clinical research studies
• Demonstrates extensive experience in statistical data analysis of clinical trials (Phase 1-3) as well as integrated data analyses of safety and efficacy.
• Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
• Authors or oversees authorship of Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs). Ensure rigorous approaches are taken to ensure good scientific practices as followed: proper statistical methods utilized in analysis plans, and assay methods are appropriately designed, blinded, and randomized to meet objectives.
• Makes statistical contributions to clinical study reports, including authoring of statistical methods, data interpretation Clinical Study Reports (CSRs), and manuscripts for publication / presentation.
• Accounts for statistical activities in support of IND/NDA or other regulatory submissions. Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs.
• Experience in statistical programming (SAS and R) and other relevant statistical analysis software systems.
• Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety data and for benefit-risk analyses
• Performs exploratory statistical analyses and quantifies the benefits, risks, values and uncertainties of drug research and development to make sound conclusions and propose drug development strategies.
• Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP).
• Provides statistical guidance/oversight to statisticians regarding requirements and GCP standards.
• Works collaboratively with multi-function teams to complete project deliverables per agreed timelines.
• Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions

Qualifications:

• MS in Statistics, Biostatistics, or a highly related field with 6+ years of industry experience in drug development
• PhD in Statistics, Biostatistics, or a highly related field with 3+ years industry experience in drug development
• Ability to clearly communicate fundamental statistical concepts to other statisticians, scientists, and other personnel across various global teams

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status