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