Principal Statistical Programmer (PK/PD) (m/w/d)

Tasks

• Create analysis ready PopPK PKPD and exposure response datasets
• Design PK PKPD and safety ADaM datasets
• Develop QC processes macros and standard programming practices
• Develop SDTM and ADaM datasets
• Develop TLF outputs
• Ensure timelines quality and documentation compliance
• Implement PK parameter pooling strategies
• Lead CDISC dataset development and validation
• Mentor junior programmers and guide delivery
• Provide programming leadership for Phase I first in human and crossover designs
• Support PopPK PKPD and exposure response analyses
• Support integrated analyses and pooled PK datasets
• Support regulatory submissions

Perks/Benefits

• N/A

Skills/Tech-stack

ADaM | CDISC | Crossover study | Exposure-response | First in human | PK | PK parameter pooling | PKPD | Poppk | QC | SAS | SDTM | Safety data | TLF