Senior Scientist, Biostatistics, CMC Statistics Full-time

Biostatistical Leadership Role in Drug Development

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.

Responsibilities

The role involves 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. The individual serves as a statistical lead in project teams, managing multiple projects independently and supporting scientific protocols. They represent the statistical function in cross-functional teams and contribute to department and therapeutic area goals. Participation in professional societies and technical associations is also expected.

Primary Activities

Key activities include acting as the statistical representative and lead in cross-functional teams for strategic planning and product development execution. The role requires 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 is essential. Additionally, mentoring junior staff is part of the responsibilities.

Education and Minimum Requirement

Candidates should hold a PhD or equivalent degree in statistics, biostatistics, or a related field. Alternatively, a Master's degree in Statistics or Applied Statistics with at least three years of relevant experience is acceptable.

Required Skills and Experience

The role demands 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 is required. The individual should demonstrate the ability to learn proactively, be motivated, detail-oriented, and capable of working independently. Strong communication skills and effective collaboration across functions are also necessary.

Preferred Skills and Experience

An understanding of disease biology and drug discovery and development is preferred for this position.

Required Skills:

Biostatistics, Collaborative Communications, Data Analysis, Data Management, Data Science, Detail-Oriented, Numerical Analysis, Pharmaceutical Development, Scientific Modeling

Salary Range

$117,000.00 – $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.