Director – Biostatistics

Director – Biostatistics

Requirements

• PhD. in Biostatistics and 10+ years of relevant work experience, or M.S. in Biostatistics and 13+ years of relevant work experience
• Hands-on Experience in INDs, NDAs, MAAs, or other regulatory submissions
• In-depth knowledge of statistical methods for clinical trials
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• Proficient in statistical programming (SAS and R)
• Experience leading statistical efforts for multiple studies
• Fluent in data standards, including SDTM and ADaM
• Experience with outsourced statistical services provided by CROs

Responsibilities

• Provide strategic input to optimize trial designs in late phase registrational studies
• Work with internal and external statistical programming team members on the planning and execution of statistical deliverables
• Conduct statistical simulations to ensure robust and efficient statistical designs and address identified or potential statistical issues arising with studies
• Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
• Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
• Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
• Perform QC/QA of statistical deliverables including validation of main analysis results
• Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
• Accountable for assigned statistical activities to support IND/NDA/MAA or other regulatory submissions; provide review for required components of regulatory submissions including appropriate datasets, define files, reviewer’s guides, and other relevant documents
• Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
• Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
• Represent VIR regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
• Support inspection readiness activities

Preferred Qualifications

No preferred qualifications provided.