Senior Scientist, Pharmacometrics

Job Title: Senior Scientist, Pharmacometrics

Job Location: High Wycombe, UK

Job Location Type: Hybrid

Job Contract Type: Full-time

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at  As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Discovery & Pre-Clinical/Clinical Development

Pharmacokinetics & Pharmacometrics

Scientific/Technology

High Wycombe, Buckinghamshire, United Kingdom

About Innovative Medicine

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. Learn more at  Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium - Requisition Number: R-060352 United States - Requisition Number: R-057852 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 Pharmacometric (PM) support team is mainly passionate about data programming, data quality control (QC), analysis QC and e-submission related aspects.

• 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. 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 Study Data Tabulation Model/Analysis Data Model (SDTM/ADAM) datasets or in sources in other formats, in some cases extensive data cleaning and complex calculations are needed.
• Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated 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.…