paid / United States (Titusville, New Jersey; Spring House, Pennsylvania; Raritan, New Jersey) / full-time
Janssen is recruiting a Pharmacometric PK/PD programmer (Scientist) in the US (NJ/PA). 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 PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of 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.
Your key responsibilities:
- Prepare programming scripts (e.g. R, SAS) to generate 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 calculation 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, BAN/BDS, EPOD) and external Vendors (for example PK office 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 (e.g. R script which can automate the linking of documents).
- Experience with data plotting in R is desired (e.g. ggplot2).
- Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements
We would love to hear from YOU, if you have:
Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume.
- B.S. Degree or equivalent with 3 to 5 years of experience in pharmaceutical industry or M.S. Degree with 1-2 years of experience in pharmaceutical industry.
- Expertise in one of the programming languages which are commonly used in data assembly community (e.g. R and/or SAS).
- Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM
- Knowledge of principles of non-linear mixed effect modelling
- A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts
- Good written and oral communication skills
- 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)
- Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently in a timely manner (planning and organizing)
- Attention to detail
- Contributing to the organization assuming responsibility and accountability for successfully completing assignments or tasks (delivery of results)
- Actively identifying new areas for learning and application to the job (continuous learning)
- Good sense of cultural sensitivity and diversity (cultural diversity)
- Self-motivated with the ability to work independently with minimal direction (personal accountability)
- Estimated travel of about 5% of time
Please message me directly or apply via link below:
Clinical Pharmacology and Pharmacometrics
Janssen Research & Development