DIRECTOR STATISTICAL PROGRAMMING

Company: Aura BioSearch
Location: Boston
Posted on: October 31, 2024

Job Description:

Director Statistical Programming Were seeking a Director of Statistical Programming to lead statistical programming activities for clinical development programs and manage vendor oversight. This role will collaborate closely with biostatisticians data managers and crossfunctional teams and will be an inhouse expert in programming and data standards. Key Responsibilities:

• Lead and manage programming for clinical trials ensuring quality and adherence to timelines.
• Collaborate on programming strategies and support regulatory submissions.
• Develop and maintain analysis datasets tables and figures following CDISC standards.
• Provide technical guidance to junior programmers and foster their growth.
• Stay current with industry trends and introduce innovative solutions. Requirements:
  • MS in Statistics Computer Science or related field with 10 years of experience or BS with 12 years.
  • Proficiency in SAS programming and macro development; R knowledge preferred.
  • Familiarity with ICH guidelines CDISC standards and regulatory requirements. Onclogy experience preferred.
  • Experience in NDA/BLA or other regulatory filings.
  • Strong leadership communication and organizational skills.Remote Work : No

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