Type:

full-time

Job Description:

Statistical Programmer

Fractional Contract | Medical Device / Drug | Philadelphia ?

???

Contract Type:

Part-Time Fractional Contract (~20 hrs/week) ??

Location:

Philadelphia ????

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

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