Associate Principal Scientist, Biostatistics, Clinical Safety Statistics
MSD
full-time
Posted on:
Location Type: Hybrid
Location: North Wales • New Jersey • Pennsylvania • United States
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Salary
💰 $142,400 - $224,100 per year
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysissurvival analysismeta-analysisBayesian analysisclinical trial designsafety data analysisSDTM datasetsADaM datasetsstatistical graphicsstatistical methods
Soft Skills
leadershipcollaborationcommunicationteamworkstrategic planningproblem-solvinginterpersonal skillsorganizational skillspresentation skillsresearch skills
Certifications
PhD in statisticsPhD in biostatisticsMaster's degree in related discipline