Contract Statistical Programmer
Apex Systems Inc
Our rare disease focused biotechnology client is looking for a seasoned Statistical Programming leader ready to drive highimpact clinical deliverables with autonomy and technical excellence. This role leads projectlevel programming strategy, guides teams, and ensures flawless execution across complex studies.
What You'll Do- Lead development of SAS programs, TLFs, and CDISCcompliant SDTM/ADaM datasets.
- Own and review SDTM/ADaM specifications and ensure highquality, ontime outputs.
- Oversee documentation for analysis, reporting, and regulatory submissions.
- Build advanced SAS macros and tools to streamline workflows.
- Ensure alignment with SOPs and FDA/ICH/GCP standards.
- Represent Statistical Programming in crossfunctional and external technical discussions.
- Support process improvements, system validation, and technology adoption.
- PhD with 5+, or MS with 7-10 years of industry experience, or BS with 9-12 years.
- Handson experience with BLAs, MAAs, and regulatory submissions; CNS experience a plus.
- Deep SAS expertise (macros, Base SAS, SAS/STAT, SAS/GRAPH); SAS LSAF experience helpful.
- Strong command of ADaM standards and integrated ADaM development.
- Experience contributing to ISS/ISE.
- Excellent communication skills and the ability to influence across teams.
- Highly organized, proactive, and comfortable in fastmoving environments.
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