Biostatistician

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 #J-18808-Ljbffr