• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Statistical Programming Dir.

Job Number: 34386

Location:

Job Description

Join our expanding clinical team as the first Associate Director/Director, Statistical Programming. Reporting to the Head of Development Operations, you'll oversee all statistical programming deliverables, ensuring compliance with company SOPs and ICH/GCP guidance, and collaborate closely with the Director of Biostatistics to put in place programming policies and procedures.

Responsibilities

  • Oversee statistical programming for various tasks.
  • Collaborate with biostatisticians and IT teams to maintain secure computing infrastructure.
  • Manage personnel and contractors for quality deliverables within budget.
  • Review study documents.
  • Ensure compliance with industry standards for data specifications.
  • Author or review SOPs as necessary.
  • Perform ad hoc analysis and data review.
  • Establish project timelines and conduct statistical analyses efficiently.
  • Develop and manage resources for data processing.
  • Fulfill additional responsibilities as needed.

Required Skills

  • Bachelor’s/Master’s in relevant field with 10+ years of statistical programming experience
  • Proficient in industry standards for clinical study data and regulatory reporting
  • Advanced SAS programming skills.
  • Experience in oncology is a plus.
  • Extensive leadership in early-phase clinical studies.
  • Demonstrated ability to manage outsourced programming tasks.
  • Expertise in electronic submission requirements and technology.
  • Strong analytical and communication skills.

 

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