Principal Scientist Pharmacometrics Support Full-time

Principal Scientist, Pharmacometrics Support

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Principal Scientist, Pharmacometrics Support to be located in Spring House, PA; Raritan, NJ; Titusville, NJ; Beerse, Belgium; or High Wycombe, United Kingdom.

This position is responsible to support the Pharmacometrics Leader (PML) or Clinical Pharmacology Leader (CPL) who is the modeling lead in development and execution of Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of Clinical Pharmacology and Pharmacometrics (CPP) sponsored and -supported studies for products in any phase of development. The Pharmacometric (PM) support team is mainly passionate about data programming, data quality control (QC), analysis QC and e-submission related aspects and process improvements.

You will be responsible for:

• Preparing R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK, PK/PD or Exposure Response analysis, based on requests from PM leader or Modeling leader.
• Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
• Upon request, QC NONMEM or ADNCA input dataset(s) generated by another PM support colleague. Log which QC script is used, which subjects were checked per study, what other aspects were checked within the dataset, the findings of the QC and the follow-up actions of those findings in a QC document.
• Generating e-submission package for NONMEM (or other modelling type) analysis. In general, the package includes NONMEM input datasets, NONMEM control file, output parameter files, output table files and other files, in addition to supporting documents such as define and var-names-descr files. PM support renames the files provided by PM leader or CPP leader, so they fit the naming convention requirements for e-submission package if needed, converts these files into the appropriate formats, and places them into the right folder structure then links them to the define and var-names-descr files. PM support works closely with EPOD team to ensure the e-submission package has the right structure, accurate formats and being placed in the right assembly server directory.
• Interacting with other departments (including but not limited to Data Management, Clinical & Statistical Programming, bio-analytical teams, Regulatory) and external Vendors to communicate the needs of CPP in data collection, data formatting, data representation and cross departmental trainings if needed. Promote better understanding across different departments.
• Piloting the generation of the first draft AI Authored data specification.
• Performing pharmacometric Analysis QC activities in support of the PM Leader.
• Driving CPP internal process improvements in dataset creation, dataset QC (e.g. a standard QC R script with a checklist), pharmacometric analysis QC procedures and e-submission package preparation; move forward existing automatizations ensuring high quality and speed.
• Overseeing internal R package updates and maintenance. Creating required training decks for internal use. Actively participating in working groups related to AI assisted code generation.
• Presenting (cross-departmental) process improvements within/outside the department.
• Carrying out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.

Qualifications / Requirements:

Education:

• A minimum of a Master's degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or a related field with 6+ years of pharmaceutical development experience OR a PhD with 4+ years of pharmaceutical development experience is required.

Experience and Skills:

Required:

• Expertise with R programming language and R function creation is required.
• A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts is required.
• Good understanding of regulatory requirements and eCTD is required.
• Good understanding of AI driven approaches within data programming is required.
• Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM is required.
• Excellent written and oral communication skills with strong attention to detail are required.
• Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships) is required.
• Ability to collaborate in a diverse global environment is required.
• Self-motivation with the ability to work independently with minimal direction is required.

Preferred:

• R Shiny programming experience is preferred.
• Prior knowledge with ADNCA and ADPPK dataset standards is preferred.
• Knowledge of principles of non-linear mixed effect modeling is preferred.
• Prior experience with pharmacometric analysis QC would be an asset.
• Experience within oncology and immunology is an asset.

The expected base pay range for this position is $117,000 to $201,250.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

Additional information can be found through the link below.

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on 04/13/2026. The Company may, however, extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants