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Programming Manager

2 months ago

Reston, Virginia, United States GQR Full time

Manager of Programming, Statistics

Location: Greater Boston, MA (Hybrid preferred) - Open to Remote (EST Only)

Salary: $150k-165k

Work Type: Prefered Hybrid (3 days in-office, 2 days remote)

GQR is seeking a skilled Manager of Programming, Statistics to join our team. As a key member of our biopharmaceutical company, you will be responsible for overseeing statistical programming activities across various studies and phases. Your expertise will be essential in collaborating with cross-functional teams and managing relationships with external contract research organizations (CROs).

Key Responsibilities:

  • Lead all statistical programming activities for assigned studies, ensuring compliance with regulatory guidelines and timelines.
  • Oversee CROs and other external vendors, ensuring high-quality and timely delivery of clinical data and statistical analyses.
  • Collaborate cross-functionally to design and develop study documents, including SDTM and ADaM packages.
  • Perform quality control for statistical programming deliverables, ensuring accuracy and completeness.
  • Lead user acceptance testing for clinical databases and study data.
  • Participate in ongoing data reviews and contribute to the preparation of clinical study reports.
  • Ensure statistical programming compliance with regulatory requirements and industry best practices.

Qualifications:

  • Master's degree or higher in Statistics, Mathematics, Computer Science, or a related field.
  • Minimum of 5 years of statistical programming experience within the pharmaceutical industry or Biotech industry.
  • Proficiency in SAS programming and development of SDTM, ADaM packages, and clinical study data analysis.
  • Strong knowledge of regulatory guidelines, GCP, and clinical trial processes.
  • Manage external vendor relationships.