**This opening will begin interviewing in May/June 2026***
Consultant Statistical Programmer (remote)
A clinical-stage Biotech seeks an experienced Consultant Statistical Programmer.
Responsibilities:
- Provide programming support across Phase II and III studies.
- Develop, validate, and maintain SDTM and ADaM datasets, as well as TLFs for regulatory submissions.
- Ensure high-quality, accurate, and timely programming deliverables.
- Collaborate with CROs and vendors to oversee programming deliverables and resolve any technical issues.
- Partner with cross-functional teams including Biostatistics, Clinical Operations, and Regulatory Affairs.
Requirements:
- Advanced degree (Master’s or Bachelor’s) in a relevant field such as Computer Science, Statistics, or related discipline.
- 10-15+ years industry experience.
- Extensive experience with late-phase trials, including regulatory submission support (e.g., NDA/BLA).
- Extensive hands-on experience with SAS (and/or R if applicable) for generating SDTM, ADaM, and TLFs.
- Excellent communication skills with the ability to collaborate effectively across teams.
Rate dependent on experience and engagement type – $80-150 per hour