Principal Scientist Manufacturing Statistics

Johnson & Johnson Innovative Medicine Research & Development is recruiting a Principal Statistician to join the Manufacturing Team within the Discovery & Manufacturing Statistics (DMS) department.

The Manufacturing team within the DMS department, part of the Statistics and Decision Sciences organization at J&J, provides vital statistical support for the design and analysis of manufacturing studies in research and development context. The work integrates statistical methods with scientific and engineering principles. Their expertise spans a wide range of areas, covering compounds, programs, and technologies throughout all phases of pharmaceutical research and development. The goal is to ensure the quality, safety, and continuous supply of our portfolio medicines, ultimately benefiting patients worldwide. DMS represents a global team of statisticians located in Beerse (Belgium), Leiden (The Netherlands), Prague (Czechia), Boston (MA, USA), Spring House (PA, USA), Raritan (NJ, USA) and La Jolla, (CA, USA) campuses.

Job Description

We are seeking a Principal Statistician to lead advanced statistical modeling efforts in support of manufacturing programs across therapeutic modalities (synthetics, proteins and advanced therapies). The role will drive development and deployment of predictive models, spectral deconvolution and chemometric workflows, reaction fingerprinting, and spectroscopic screening. The successful candidate will partner closely with chemists, formulation and stability scientists, and process engineers.

Key responsibilities for this exciting and unique role are:

• Lead statistical strategy and execution for projects including solubility modeling and prediction; accelerated stability and shelf-life estimation; reaction trend fingerprinting and outlier detection; dissolution modeling; mechanistic modeling; and spectral analytics (ssNMR, THz-Raman, XRD).
• Develop design of experiments and Bayesian Optimization workflows to accelerate method development and reaction optimization.
• Lead chemometric and spectral analysis pipelines
• Work closely with researchers on experimental design, data analysis, interpretation, and clear communication of evidence to support research, development, and product commercialization.
• Co-author scientific publications and present research findings at internal and external forums.
• Build and maintain trusted relationships with colleagues and stakeholders through clear, reliable statistical guidance.
• Support internal capability building through statistical trainings, mentorship, and the development and dissemination of best practices and reproducible workflows.

Minimum (required) Qualifications

Education:

• Advanced degree in Statistics, Biostatistics, Chemometrics or a closely related discipline. (Ph.D. preferred; M.S. considered with exceptional experience)

Experience and Skills:

• Minimum 5 years of applied statistical modeling experience in pharmaceutical, biotech, or chemical process environments, or equivalent industry experience.
• Strong expertise in Bayesian and frequentist methods, including experience with design of experiments.
• Hands-on programming proficiency in R and/or Python.
• Demonstrated ability to lead cross-functional collaborations and to present complex statistical concepts clearly to non-statistical audiences.
• Advocate of reproducible code, robust documentation, and sound data governance practices.
• Strong communicator capable of building trust across scientific, engineering and product teams.

Preferred Skills:

Advanced Analytics, Biostatistics, Clinical Data Management, Collaborating, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design

Hybrid Work