Senior Director of Statistical Data Management

4 weeks ago


Boston, Massachusetts, United States Aura BioSearch Full time

Aura BioSearch seeks a highly experienced Senior Director of Statistical Data Management to lead statistical programming activities for clinical development programs and oversee vendor partnerships.

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 cross-functional teams and vendors.
  • Stay current with industry trends and introduce innovative solutions.

In this role, you will leverage your expertise in SAS programming and macro development to drive the development of high-quality data products. Your strong organizational skills and ability to communicate effectively with cross-functional teams will enable you to make significant contributions to our organization.

We are looking for a motivated individual who can work collaboratively with our team to achieve our goals. If you have a passion for statistical programming and a commitment to delivering high-quality results, we encourage you to apply.

The estimated salary for this position is $175,000 per year, based on industry standards and location considerations.

Requirements:
  • MS in Statistics, Computer Science, Life Sciences or related field with 8+ years of experience in statistical programming.
  • Expert in SAS programming and macro development.
  • Familiarity with ICH guidelines, CDISC standards, and regulatory requirements. Oncology experience preferred.
  • Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
  • Experience in NDA/BLA or other regulatory filings.
  • Strong communication, and organizational skills.


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