Statistical Programmer

Statistical Programmer — Fractional Contract | Medical Device / Drug | New Jersey

Impact: Deliver FDA-facing statistical programming for high-stakes medical device programmes

About

A leading specialist medical device biostatistics consultancy is growing its bench of expert contract programmers to support an expanding portfolio of FDA-facing clinical programmes. Clients are predominantly PE-backed medical device sponsors in spinal, neurological, and adjacent device therapy areas — companies operating under intense regulatory scrutiny where the quality of statistical work directly shapes regulatory outcomes.

This is a senior-only shop. Everyone on the team was hired to do the work — not manage it. If you're a programmer who wants to stay close to meaningful science and work at pace with people who set the standard, this is worth your attention.

Why

Fractional hours. Exciting and fast-paced work. This role is built for programmers who want flexibility without stepping away from high-quality, impactful clinical programmes. You'll be embedded in active medical device trials from day one, working directly alongside senior FDA-facing biostatisticians — and for those with regulatory ambition, there is a clear and supported pathway to get there.

What You'll Do

• Develop and deliver SAS and/or R programmes across active medical device clinical trials
• Build and validate datasets, tables, figures, and listings to regulatory-ready standards
• Collaborate directly with senior biostatisticians on sponsor-facing deliverables
• Respond to time-sensitive requests with pace and precision — FDA timelines are real
• Develop regulatory knowledge over time, with mentorship available from senior leadership

Requirements

• Strong hands-on SAS and/or R programming experience — active delivery, not oversight
• Background in clinical trials or a regulated data environment
• Medical device experience is a significant advantage — not an absolute requirement
• CDISC familiarity is useful but not mandatory — device programmes operate differently
• Intrinsically curious, eager to learn, and proactive — this team rewards people who go beyond the brief

Why It's Special

• Fractional and flexible — ~20 hours per week with room to grow
• Direct access to some of the most experienced FDA-facing biostatisticians in the device space
• Clear pathway into regulatory science for the right candidate
• Work on genuinely high-stakes programmes for well-capitalised device sponsors
• Senior-only environment — no layers, no noise, just high-quality work