Associate Statistical Programming Director Job at Exelixis, Alameda, CA

  • Exelixis
  • Alameda, CA

Job Description

Associate Statistical Programming Director leads statistical programming activities for clinical studies using SAS and R. Responsibilities include developing macros, datasets in SDTM/ADaM formats, analysis programs, and overseeing quality control of programming deliverables while ensuring FDA compliance and CDISC standards.

Responsibilities

  • Maintain macro library, provide training, and serve as primary contact for macro questions
  • Independently develop SAS and R programs for study analyses following SDLC standards
  • Coordinate with data management and biostatistics teams on data transfers and output delivery
  • Oversee CRO development of datasets and conduct quality control of analysis deliverables
  • Lead programming resource allocation and coordinate work of other statistical programmers on projects

Requirements

  • BS/BA in related discipline plus 11 years experience, or MS/MA plus 9 years, or PhD plus 5 years
  • Minimum 8 years pharmaceutical/biotech statistical programming experience
  • Proficiency in R, SAS/Base, SAS/Stat, and SAS/Macros
  • Strong analytical and business communication skills, written and verbal
  • Experience with UNIX, CDISC standards, and SAS graphics (desirable)
  • Oncology clinical trials or NDA submission experience (preferred)

Compensation: $165,500-$235,500 base annually

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