CAR T Process Analytics Lead

Job Description

Janssen Pharmaceutical, a member of Johnson & Johnsons Family of Companies, is recruiting for a CAR-T Process Statistician .

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

The CAR-T Process Statistician Will:

Lead the efforts in collecting, organizing and analyzing data from manufacturing and other business processes

Will work closely with the IT to build long term sustainable and compliant solutions to collect data from multiple sources while ensuring data integrity is maintained

Establish routine reports for site management and other internal and external partners

Analyze trends in manufacturing routinely and present findings to senior management

Perform regressions and multi-variate analysis to identify correlations and develop models to accurately predict manufacturing outcomes

Summarize findings using visualization softwares

Interact with multiple functions to provide data and analytics

Work in a highly fast paced environment

Support the establishment of process and business metrics.

Provide support to investigations and change controls assessments to justify change and/or help identify root causes.

Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).

Qualifications

A minimum of a Masters degree in a Mathematics, Statistics, Computer Science or related field is required

A minimum of Masters + six (6) years of professional relevant business experience is required.

Experience in Pharma/biotech industry is highly preferred

CAR-T manufacturing experience is preferred

Experience with programming languages like R and Python is required

Experience with data visualization and analysis software like Tableau, Power BI, Spotfire, is preferred

Experience as a Biostatistician is preferred.

Demonstrated ability to perform multi-variate analysis is highly desirable

Knowledge of database management software like SQL is preferred

Ability to utilize various standard programs for data entry and word processing is preferred.

Excellent written and oral communication skill are required

This position is located in Raritan, NJ and will require up to 10% of travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.