Statistical Programming Lead

Location: Remote
Compensation: Salary
Reviewed: Fri, Mar 28, 2025
This job expires in: 9 days
Statistical Programming ADaM TFL Statistical Analysis

Job Summary

A company is looking for an Analysis Oversight Statistical Programming Lead- Manager.

Key Responsibilities
  • Lead the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring compliance with regulatory standards
  • Monitor vendor performance metrics and address challenges within the study programming team
  • Coach and mentor programming colleagues while ensuring the quality and timeliness of clinical trial programming deliverables


Required Qualifications
  • PhD in Biostatistics/Computer Sciences or equivalent, or MS with 4 years of experience, or BS with 6 years of experience
  • Minimum 2 years of experience leading studies in virology, oncology, or inflammation therapeutic areas
  • Expertise in developing ADaM and TFLs and delivering high-quality statistical programming datasets
  • Strong experience in data analysis and programming, including non-compartmental Pharmacokinetics (PK) analysis
  • Deep knowledge of GCP, ICH guidelines, and regulatory requirements related to quality oversight and risk management

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