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Principal / Assoc. Director, Statistical Programming
East Coast, Remote
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A growing clinical-stage biotech is looking to bring on a Principal or Associate Director-level Statistical Programmer to help drive execution across its growing pipeline.

 

Responsibilities:

  • Serve as lead programmer across assigned clinical studies, with responsibilities spanning all phases of development.
  • Develop and validate SDTM and ADaM datasets, ensuring compliance with internal and industry standards.
  • Produce high-quality TLFs and support interim analyses, final study reports, IDMC packages, and exploratory requests.
  • Collaborate cross-functionally with Biometrics, Clinical Operations, and Regulatory teams to support data review, analysis, and submission preparation.
  • Provide technical oversight of CRO deliverables to ensure timelines, consistency, and data integrity.
  • Contribute to regulatory documents, data submissions, and response packages.
  • Support development of reusable programming standards and ensure inspection readiness across programming documentation.

 

Requirements:

  • 5+ years of industry statistical programming experience
  • Extensive hands-on SAS experience
  • Proficiency in CDISC implementation (SDTM, ADaM) and submission best practices.
  • Prior leadership of Phase II or III studies from database build through readout preferred.
  • Strong attention to detail, high sense of urgency, and ability to work in a dynamic, fast-paced environment.
  • Excellent communication skills and collaborative mindset.

 

Compensation DOE - $140k–$220k base salary + benefits

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