Principal Scientist - CMC Statistician (Pharmaceutical Statistics)

Location: Framingham, Massachusetts, United States; onsite

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.

What you will do

• Provide statistical support for CMC process, analytical method, and formulation development across multiple sites.
• Design experiments, perform data analysis, and interpret results using statistical methodologies and software.
• Conduct complex or critical studies intended for Health Authorities and prepare regulatory statistical reports, memos, and presentations.
• Act as the interface between CMC Statistics and related functions, supporting project teams and stakeholders.
• Train laboratory customers in statistical methodologies and validated applications.
• Develop advanced statistical methods and participate in technical working groups and statistician networks.

Requirements

• PhD or master's degree in Statistics, CMC Statistics, Industrial Statistics, Applied Mathematics, Data Science, Computational Biology, Bioinformatics, or a related scientific field.
• At least 3 years of CMC statistician experience with a PhD or 6 years with a master's degree.
• Knowledge of non-clinical statistics for CMC development, including analytical method validation or transfer, stability modeling, comparability studies, specification limits, or Quality by Design.
• Expertise in industrial statistics, including Design of Experiments, multivariate analysis, or statistical modeling.
• Proficiency with R or JMP; experience with SAS, Python, SIMCA, or MODDE is beneficial.
• Experience preparing technical documents, reports, presentations, and statistical analyses for regulatory purposes, with knowledge of CMC, GMP, EMA, FDA, ICH Quality, and pharmacopoeial requirements.

Nice to have

• Pharmaceutical development experience.
• Experience with complex exploratory statistical analyses and Health Authority questions.
• Experience with R/RShiny, SAS, Python, JMP, SIMCA, or MODDE in a departmental computing environment.
• Strong teamwork, communication, scientific rigor, and independence in managing statistical work packages.

Culture & Benefits

• Supportive, future-focused environment centered on scientific innovation.
• Opportunities for promotion, lateral development, and international career growth.
• Health, wellbeing, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work with AI, data, and digital platforms to advance drug discovery and development.