Senior Data Programmer

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SoTalent
United States, US
  • Pharma
  • FullTime
  • Applications have closed

Senior Manager, REMS Data Programmer (Remote)

Location: Remote (based in the U.S.)

Full Salary Range: $136,000 – $204,000 (based on experience, qualifications, and location)

A global biopharmaceutical organization is seeking a Senior Manager, REMS Data Programmer to support U.S. FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs and other patient safety initiatives. This position sits within the REMS Strategy and Operations team and plays a critical role in leading data programming activities, supporting cross-functional collaboration, and delivering actionable insights for regulatory compliance and internal decision-making. This is a remote role open to U.S.-based candidates.

Key Responsibilities:

  • Lead programming activities related to REMS and risk management data analysis.
  • Develop, validate, and review datasets, tables, listings, and figures (TFLs) in compliance with CDISC standards.
  • Build and maintain dashboards using Power BI to visualize REMS assessment data and performance metrics.
  • Write high-quality, well-documented code using SAS, R, Python, or other relevant programming languages.
  • Collaborate with cross-functional stakeholders, including business analysts, solution architects, and regulatory teams, to align data solutions with business and compliance needs.
  • Support the development, implementation, and maintenance of REMS portals and data reporting systems.
  • Assist with regulatory audits and inspections related to REMS compliance.
  • Prepare and deliver data-driven presentations to senior leadership.
  • Manage daily departmental data tasks across multiple REMS programs.

Required Qualifications:

  • 6–8 years of experience in the pharmaceutical industry, including 3–5 years in a data programming role supporting regulated environments such as REMS or pharmacovigilance.
  • Proficiency in data programming languages such as SAS , R , and Python.
  • Strong skills in data visualization and dashboard creation using Power BI.
  • Solid understanding of business analysis practices and stakeholder collaboration.
  • Experience working with CDISC standards; CDISC certification is a plus.
  • Excellent communication skills with the ability to convey complex technical information to diverse audiences.
  • Ability to work independently in a fast-paced, multi-priority environment.

Education Requirements:

  • Bachelor’s degree in Computer Science , Statistics, or a related field required.
  • Advanced degree preferred.
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