Senior Scientist, Biostatistics, CMC Statistics

Job Overview

In BARDS (Biostatistics and Research Decision Sciences) within the Research and Development division, quantitative scientists collaborate with subject matter experts to apply state‑of‑the‑art scientific methodologies and tools to support discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for patients and global health.

Provide biostatistical leadership and support for drug development projects in the CMC (Chemistry, Manufacturing & Controls) area, coordinating with internal groups such as analytical, formulation, project management, regulatory, statistical programming, data management, and manufacturing divisions. Serve as statistical lead in project teams, manage multiple projects independently, support scientific protocols, represent statistical function in cross‑functional teams, mentor junior staff, and participate in professional societies and technical associations.

• Act as the statistical representative and lead 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.

• PhD or equivalent 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, detail‑oriented, and capable of working independently.
• Strong communication skills and collaboration across functions.

• Understanding of disease biology and drug discovery and development.
• Affinity for biostatistics, collaborative communication, data analysis, data management, data science, detail orientation, numerical analysis, pharmaceutical development, scientific modeling.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

San Francisco Residents Only. Los Angeles Residents Only – qualified applicants with criminal histories are considered in compliance with applicable state and local laws.

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 affirmative action requirements for protected veterans and individuals with disabilities.

We provide accommodations during the application or hiring process as needed.