Part-Time Contract Statistical Programmer
Keros Therapeutics · MA Hybrid +1 more
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Role summary
Keros Therapeutics seeks a part-time contract statistical programmer to provide programming and analytical expertise for clinical development programs. The role involves designing SAS libraries, creating analysis specifications, overseeing CRO teams, and supporting regulatory submissions in a hybrid arrangement.
What they're looking for
- Graduate degree in biostatistics, statistics, computer science, or related field
- 8+ years statistical programming experience in pharmaceutical or CRO industry
- 3+ years managing technical professionals in regulated environments
- Strong SAS programming skills for clinical trials and macro development
- Expert knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
- Recent BLA/NDA or regulatory filing experience
- Global clinical trial and CRO management experience
What you'll be doing
- Design and establish SAS program libraries for clinical trial reporting and statistical analyses
- Develop specifications and SAS programs for data listings, patient profiles, and regulatory submissions
- Support clinical data management documents including CRFs, data management plans, and CDISC specifications
- Oversee CRO programming team activities to ensure quality and timely deliverables
- Lead SDTM/ADaM dataset programming and author data specifications for regulatory filings
Privacy & handoff
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