Associate Principal Scientist, Biostatistics, Clinical Safety Statistics

Role Overview

• Provide statistical support and leadership for projects related to the evaluation of clinical safety data.
• Interact with cross-functional Risk Management Safety Teams (RMSTs) on planning and executing evaluations of safety data for clinical development programs.
• Design, develop and evaluate processes, methods and tools for safety data evaluation.
• Collaborate with Clinical Safety and Risk Management, Clinical Research, Early Development Statistics, Late Development Statistics, Epidemiology, Scientific Programming, and other groups, on drug/vaccine safety evaluation from the Investigational New Drug (IND) through New Drug Application (NDA) to post-marketing phases of development programs.
• Provide statistical support and leadership to cross-functional RMSTs for strategic planning and statistical analysis activities supporting safety evaluations.
• Collaborate on planning and executing aggregate safety evaluations for: clinical trials during a development program, regulatory documents (e.g., DSUR, IB), and responses to safety-related inquiries.
• Ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements.
• Evaluate the appropriateness of available software for planned analyses and ascertain the need for development of novel statistical methods or programming.
• Design, develop and evaluate processes, methodology and tools for product safety evaluation to support ongoing aggregate safety data analysis.
• Prepare oral and written reports and presentations to effectively communicate safety analysis results to project teams, management, regulatory agencies, or individual investigators.
• Stay current regarding regulatory guidance and methods for the evaluation of safety data.
• Participate in research activities for innovative statistical methods and applications in clinical safety evaluation.

Requirements

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or master’s with a minimum of 6 years relevant work experience.
• Solid knowledge of statistical analysis methodologies, including survival analysis, meta-analysis and Bayesian analysis methods.
• Knowledge of and experience with clinical trial design and analysis.
• Knowledge of and experience with the analysis and interpretation of (integrated) safety data.
• Knowledge of and experience with the specifications, creation, and use of SDTM and ADaM datasets.
• Solid knowledge of statistical and data processing software e.g. SAS and/or R and R-Shiny, including generation of statistical graphics.
• Ability to function effectively in a team environment with personnel from different functional areas.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days