Director of Biostatistics

The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions.

• Contribute to strategic thinking and Clinical Development Plan (CDP) development.
• Leads large and/or complex late phase clinical development program(s).
• Promote teamwork, quality, and innovation through effective collaboration with program teams. Foster a productive work environment.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials
• Authors the statistical sections of clinical trial protocols and statistical analysis plans
• Reviews and approves stratification/randomization schema
• Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs
• Provides statistical guidance on conduct of ongoing trials
• Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADaM and ad hoc analysis specifications
• Interprets and communicates the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Leads biostatistics support for worldwide regulatory submissions
• Represents company in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
• Contributes to scientific articles, summarizing data collected in company trials
• Consults with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work
• Responsible for timeline management across their clinical development program

• Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred)
• Excellent written and oral communication and presentation skills
• Experience designing and supporting late-phase (Phase 2/3) clinical studies
• Experience conducting clinical trial simulations to evaluate design options, operating characteristics, and decision criteria
• Interest in and basic understanding of biology and biological processes, including RNAi

• Experience with Bayesian and adaptive clinical trial design
• Experience leading or supporting NDA and MAA submission
• Proficiency in SAS and R programming language
• Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities