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Senior Statistical Programming Lead

2 months ago

San Diego, California, United States RBW Consulting Full time

Position: Associate Director of Statistical Programming

Location: San Diego, CA (On-Site)

Type: Full-time

Key Responsibilities:

  • Direct statistical programming initiatives, ensuring exceptional quality in clinical program deliverables.
  • Manage relationships with external vendors regarding statistical programming outputs (SDTM, ADaM, TFLs).
  • Offer technical guidance for internal programming projects to facilitate clinical advancement.
  • Engage with multidisciplinary teams, sharing expertise in statistical programming methodologies.
  • Oversee and enhance programming infrastructure, including macro libraries, scripts, and analytical tools.
  • Guarantee adherence to data standards and actively contribute to process enhancements.
  • Establish and execute best practices to improve programming efficiency and productivity.

Qualifications:

  • Degree in Statistics, Mathematics, Computer Science, or a related discipline.
  • Over 12 years of experience in clinical SAS programming within the pharmaceutical or biotechnology sectors.
  • Expertise in SAS programming (SAS/MACRO, SAS/SQL, SAS/GRAPH, etc.).
  • Thorough understanding of CDISC standards, particularly SDTM and ADaM.
  • Familiarity with regulatory submission packages (cSDRG, ADRG).
  • Strong grasp of medical dictionaries (MedDRA, WHODrug) and clinical data management practices.
  • Experience with rare diseases and oversight of CROs/Biostatistics vendors is preferred.