Senior Scientist, Biostatistics, CMC Statistics

MSD • Rahway, NJ

22h • Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This job description outlines the responsibilities, primary activities, educational requirements, and skills needed for a biostatistical leadership role in drug development, particularly within the Chemistry, Manufacturing, and Controls (CMC) Statistics area in biologics.

Requirements

• PhD or equivalent degree in statistics, biostatistics, or a related field, OR a Master’s degree in Statistics or Applied Statistics with at least three years of relevant experience.
• Knowledge of statistical analysis methodologies and experimental design, including mixed models, variance component analysis, equivalency studies, nonlinear regression, and Bayesian analysis.
• Proficiency in statistical software such as JMP, SAS, and/or R.
• Ability to learn proactively.
• Motivation.
• Detail-oriented.
• Capability of working independently.
• Strong communication skills.
• Effective collaboration across functions.

Nice To Haves

• Understanding of disease biology and drug discovery and development.

Responsibilities

• Providing biostatistical leadership and support for drug development projects in CMC area.
• Coordinating with various internal groups such as analytical, formulation, project management, regulatory, statistical programming, data management, and manufacturing divisions.
• Serving as a statistical lead in project teams, managing multiple projects independently and supporting scientific protocols.
• Representing the statistical function in cross-functional teams and contributing to department and therapeutic area goals.
• Participating in professional societies and technical associations.
• Acting as the statistical representative and lead in cross-functional teams for strategic planning and product development execution.
• Developing data analysis plans and selecting appropriate statistical methodologies to analyze and interpret data from CMC-related studies.
• Preparing reports to communicate results to project teams, management, regulatory agencies, or scientists.
• Mentoring junior staff.

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
• Annual bonus
• Long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior