Johnson & Johnson Innovative Medicine - Senior Scientist - Pharmacometrics Support

paid / NJ or PA, USA, remote can be considered. / full-time


Are you a talented and experienced Pharmacometrics PK/PD Programmer with advanced skills in R programming software? Are you well-versed in global data submissions and automation processes? If so, we have a fantastic opportunity for you!

If you are a highly motivated individual with a passion for pharmacometrics and a proven track record in programming, we would love to hear from you! Join our talented team as a Senior Pharmacometrics Support Scientist and make a significant impact.

Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for a Senior Scientist, Pharmacometrics Support. The preferred location for this position is either Spring House, PA, Raritan, NJ or Titusville, NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.

The 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 PM support team is mainly passionate about data related and e-submission related aspects.

Key Responsibilities:

  • Prepare R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK and/or PD analysis, based on requests from PM leader or Modeling leader. During dataset generation, PM support also modifies the variable definition file (PM leader or CPP leader is the main author of this document) which clearly defines each variable within this dataset with any additional information as they see fit. The NONMEM input dataset(s) created could be for interim or final analysis. The source used could be interim (uncleaned) or final SDTM/ADAM datasets or in sources in other formats, in some cases extensive data cleaning and complex calculations are needed.
  • Upon request, QC NONMEM 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.
  • Generate 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.
  • Interact with other departments (including but not limited to Data Management, 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.
  • Improve CPP internal processes in dataset creation, dataset QC (e.g. a standard QC R script with a checklist) and e-submission package preparation; move forward existing automatizations ensuring high quality & speed.
  • Present (cross-departmental) process improvements within/outside the department.
  • Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.

QUALIFICATIONS

  • A minimum of a Master’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or other related discipline with a minimum of 5 years of pharmaceutical development experience is required, OR a PhD in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or other related discipline with a minimum of 2 years of pharmaceutical development experience.
  • Expertise with R programming language and R function creation is required.
  • R Shiny programming experience is strongly preferred.
  • Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM is required.
  • Knowledge of principles of non-linear mixed effect modelling is preferred.
  • 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.
  • Experience within oncology and immunology would be an asset.
  • 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) are required.
  • Ability to collaborate in a diverse global environment is required.
  • Self-motivation with the ability to work independently with minimal direction is required.
  • Estimated travel of about 5% of time

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. The anticipated base pay range for this position is $113,000 to $195,500. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. 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. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.


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https://jobs.jnj.com/en/jobs/2406168153w/senior-scientist-pharmacometrics-support/

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