Senior Scientist, Biostatistics, CMC Statistics

Job Description

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.

The role involves providing biostatistical leadership and support for drug development projects in the CMC area, coordinating with 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.

• Act as the statistical representative and lead in cross‑functional teams for strategic planning and product development execution.
• Develop data analysis plans and select appropriate statistical methodologies to analyze and interpret data from CMC‑related studies.
• Prepare reports to communicate results to project teams, management, regulatory agencies, or scientists.
• Mentor junior staff.

• Ph.D. 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, be motivated, detail‑oriented, and capable of working independently.
• Strong communication skills and effective collaboration across functions.

• An understanding of disease biology and drug discovery and development.

$ – $

We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance benefits for employees and families; retirement benefits including 401(k); paid holidays; vacation; and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC resources.

• Employee Status:
  Regular
• Relocation:
  Domestic
• VISA Sponsorship:
  Yes
• Travel Requirements: 10%
• Flexible Work Arrangements:
  Hybrid
• Shift: Not Indicated
• Valid Driving License:
  No
• Hazardous Material(s):
  None
• Job Posting End Date: 07/6/2026