Statistical Programmer (Part-Time, Full-Time)
Biomedical Statistical Consulting® (BSC®) | Philadelphia, PA preferred on-site (Remote/Hybrid for exceptional candidates)
About BSC®
For nearly 40 years, Biomedical Statistical Consulting® (BSC®) has provided biostatistics and FDA regulatory consulting to med-tech and life sciences companies. We work with organizations ranging from early-stage startups to established industry leaders across 510(k), De Novo, and PMA pathways, spanning medical devices, diagnostics, and therapeutics. Our work covers every stage of the product lifecycle, from early feasibility studies through pivotal trials and post-submission support, using methods such as Bayesian design, adaptive trial design, and propensity score matching. Every engagement is led by senior biostatisticians and regulatory specialists, several with direct FDA advisory panel experience, so new team members work alongside seasoned experts rather than being handed off to a junior team.
Role Overview
We're looking for a statistical programmer who can step in and contribute to on-going programming and client engagement. This includes cleaning and QC'ing datasets, building statistical programs, and producing accurate tables, listings, and figures on our current client projects. Part of this work will also include working directly with clients as questions and changes happen with ever evolving and new studies.
We're looking for someone who has excellent programming skills and who is genuinely motivated to continue learning and building toward a broader skill set on both the programming and clinical side.
Eager to learn new statistical software, models, tools, and programming environments as project needs evolve
Comfortable working closely and collaboratively with senior biostatisticians, including hands-on pair programming and day-to-day coordination
Available and confident engaging directly with clients in meetings to discuss study needs, deliverables, and progress
Eager to learn the Regulatory side of Biostatistics
Willing to to interface with the FDA and other regulatory bodies and learning the process of doing so
We're a tight knit team where every consultant works closely with our statistical leadership and sees projects through from raw data to finished submission. This is a great opportunity to work along side decision makers and companies on the cutting edge of medical breakthroughs.
What You'll Be Doing
You will work directly with clients to support programming and working with standardized data sets to review before high stakes submissions. Key aspects of this role are:
Receive raw or partially cleaned client datasets and independently work out structure, quirks, and quality issues
Build and maintain SAS and/or R programs to clean, derive, and QC analysis datasets
Produce tables, listings, and figures (TLFs) according to Statistical Analysis Plans and programming specifications
Translate a datasets into a clear, plain-language summary that a biostatistician can act on without re-deriving it themselves
Support CDISC-structured data (SDTM/ADaM), where applicable
Report progress and hours regularly, consistent with a part-time, variable-hours schedule
What Success Looks Like
We are a collaborative and ever evolving team. This role will grow alongside the firm and we want to support learning and higher level programming, thus:
Datasets are programmed, QC'd, and explained accurately and on time
A biostatistician can rely on your summary of a dataset without needing to re-check the raw file themselves
You proactively ask questions, flag what you don't yet understand, and act on feedback
Over time, you show measurable growth toward biostatistics fundamentals and regulatory concepts
Qualifications
B.S., M.S./ PhD in Statistics, Biostatistics, Computer Science, or a related quantitative field
Demonstrable proficiency in SAS and/or R for data manipulation, derivation, and reporting (high level programming in other languages may be required as well)
Experience with clinical trial or other regulated healthcare datasets preferred
Familiarity with CDISC SDTM/ADaM a plus, but not required
Ability to independently read and interpret a dataset, and explain it in plain language to a non-programmer
A genuine, demonstrable interest in growing into biostatistics and regulatory work
Familiarly with client meetings, billable hours and client engagement
Schedule & Criteria to Continue
Schedule: Part-time, variable hours
Rate: Commensurate with experience, paid hourly
Location: Philadelphia, PA preferred (in-person or hybrid); remote considered for exceptional candidates
Reliable, accurate, on-time programming and QC deliverables
Continuing in this part-time role is assessed on an ongoing basis against two criteria:Demonstrated eagerness to develop biostatistics knowledge and a regulatory background over time
Availability to attend meetings as needed, including client and internal check-insThese criteria are reviewed at defined check-ins.
Introductory period - 180 days
Continued engagement is contingent on meeting these criteria and is not guaranteed." And consider stating what the introductory period means (e.g., engagement may be ended during or at the end of the 180 days based on these criteria)