Manager, Statistical Programming PK/PD

The Lotus Group LLC
NJ, United States
Full-time

Overview :

In this role, you’ll be responsible for using diverse programming tools to integrate data from various sources for pharmacometrics analyses, contributing to regulatory filings and internal clinical decision-making.

You’ll create analysis datasets for Quantitative Clinical Pharmacology (QCP) modeling experts, generate tables, listings, and figures, and support pharmacometric reports and electronic submission datasets with the help of other experts.

Key Responsibilities :

  • Utilize SAS and other tools to integrate clinical data across studies for NONMEM and other modeling platforms.
  • Implement complex algorithms to handle data integration challenges.
  • Prepare tables, listings, and figures for pharmacometric reports included in regulatory submissions.
  • Optimize workflows for pharmacometric analyses, focusing on integrated datasets and analysis reports.
  • Develop efficient data integration workflows.
  • Collaborate with QCP scientists to coordinate multi-study data integration and reporting plans.

Qualifications :

  • Bachelor’s in engineering, science, computer science, mathematics, statistics, informatics, data sciences, or related field (Master’s preferred).
  • 3+ years with SAS, R, and / or Python.
  • 3+ years in SAS programming within clinical trials.
  • Familiarity with CDISC standards (SDTM, ADaM) and experience with quality control and program validation.
  • Preferably, 4+ years of industry experience with a B.S. or 1+ years with an M.S.
  • 2 days ago
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