Senior Statistical Programmer, Early Stage Development and Pharmacokinetic/pharmacodynamic Modeling and Simulation (hybrid)

Merck Merck · Pharma · PA

Senior Statistical Programmer responsible for high-quality statistical programming deliverables for early development statistics and PK/PD modeling and simulation. This includes gathering user requirements, retrieving and transforming data, developing tables, listings, and figures, and preparing compliant programming code for regulatory submissions. The role involves collaboration with statisticians, modelers, and other functional areas, and supporting the development of programming standards.

What you'd actually do

  1. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
  2. Ensure programmatic traceability from data source to analysis/modeling result
  3. Support the development of programming standards to enable efficient and high-quality production of programming deliverables
  4. gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan
  5. The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.

Skills

Required

  • SAS programming
  • SAS/MACRO
  • SAS/GRAPH
  • CDISC SDTM and ADaM standards
  • clinical endpoint data programming
  • statistical terminology and concepts
  • SAS programming experience in a clinical trial environment

Nice to have

  • R
  • Python
  • NonMem
  • clinical pharmacology concepts
  • pharmacokinetics concepts
  • reporting processes (SOPs)
  • software development life-cycle (SDLC)

What the JD emphasized

  • SAS programming experience in a clinical trial environment
  • SAS and clinical trial programming