We are seeking a Principal Biostatistician responsible for designing, monitoring, and analyzing clinical trials as well as solving statistical problems for R&D, QA, QC and Marketing and Manufacturing.

• Manages resources, project priorities and timelines for assigned projects and clinical trials, as well as manages resources across all biostatistics projects.
• Expert resource for investigating and implementing complex statistical theory and methods.
• Key participant in strategy development and contingency planning.
• Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
• Mentors and directs more junior biostatisticians.
• Act as key or primary contributor to FDA (and other regulatory) interactions regarding experimental design and statistical analysis.
• Designs, documents, tests and implements complex statistical analysis methods in collaboration with Clinical Affairs and other departments.
• Ensures biostatistical methods, equipment and practices are in compliance with current regulatory regulations and guidelines.
• Ensures statistical integrity of tables/listings/graphs and statistical analyses that support regulatory submissions and formal organizational statements and documents such as press releases and annual reports.
• Maintains expertise in state-of-the-art statistical analysis techniques.
• Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
• Develops programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
• Provides input on Data Management SOPs and develops Biostatistical SOPs and work instructions.
• Writes and/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviews table/listing/graph shells for statistical analyses and reports.
• Interfaces with clinical investigators and scientists to determine protocol design.
• Writes and/or reviews the statistical and data analysis sections for regulatory submissions.
• Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.

• Advanced knowledge of CRF and database development, including attribute assignment and logic checking.
• Advanced knowledge of applicable FDA regulations and policies regarding study design, conduct, monitoring and data analysis software program validation for database design and clinical trial data management.
• Expert knowledge of statistical software packages such as SAS, JMP or R.
• Expert knowledge of common and highly complex statistical theory and methods for clinical trials, design of experiment and quality control.
• Knowledge of business strategy, product development and risk mitigation.
• Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
• Knowledge of infectious disease, cancer, genomics and common public health issues.
• Good technical writing skills.

• BS or MS
• MS preferred
• Degree in statistics or closely related field strongly preferred

• 8-10 years related experience (MS)
• 10-12 years related experience (BS)