responsible for designing, monitoring, and analyzing clinical trials as well as solving statistical problems for R&D, QA, QC and Marketing and Manufacturing.
Duties & Responsibilities:
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
Degree in statistics or closely related field strongly preferred
8-10 years related experience (MS)
10-12 years related experience (BS)