Senior Statistical Programmer

2 weeks ago


Trenton, New Jersey, United States EG Life Sciences Full time

NO THIRD PARTY CANDIDATES
Eliassen is looking to add to our PK/PD FSP team, servicing a large Pharmaceutical client.

Detailed Job overview/ requirements
Ability to contribute to and lead standardization of processes for PKPD group including dataset creation, QC process, request process
Strong communication and timeline negotiation skills and ability to work cross-functionally with Pharmacology and Clinical Study Teams
Ability to train/mentor junior team members around PKPD programming and process
Provide and QC analysis-ready datasets (preferably using R) for Pop PK, PKPD, ER analyses and standardize process to optimize timeline with CSR programmers and analysts – R vs SAS, timeline, use of mock data
Produce and deliver NONMEM datasets (consists of three basic components; the dosing records, observations i.e. the PK/PD results, and covariates (PD baseline and/or Demographics covariates)
Provide exploratory graphical data analysis along with the data set generation and QC.
QC of data manipulation by analysts post analysis dataset generation.
Management of submission package (datasets, model files, scripts)
Establish automated processes for Phase 1 studies
CSR support for TFL outputs; write clin pharm sections of CSRs?
R programming language exp preferred
Although SAS programmers are more common – many of industry and biotechs are using R programming language more

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