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Biostatistician (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

This role sits at the intersection of biostatistics, clinical development, and regulatory strategy. At the heart of BSC, we are consultants first and biostatisticians second, and no two projects here look the same.

  • Contribute to analyses that need to withstand real regulatory scrutiny across medical device and life sciences programs

  • Run various trial and study designs day to day, gaining exposure to companies of all sizes, from early-stage startups to industry leaders

  • Take on projects with unusual designs or novel devices without established evidentiary pathways, rather than a standard textbook approach

  • Think like a problem solver first and a statistician second, building custom analytical approaches when an off-the-shelf method won't hold up

  • Feel confident enough in your reasoning to defend an approach to a client or to FDA

This is a part-time position with flexible, project-driven hours.


What You'll Be Doing

Statistical & Regulatory Leadership:

  • Lead statistical thinking on client engagements, translating clinical and regulatory objectives into sound, defensible analytical approaches

  • Design studies and trials, including non-standard designs, external controls, small-sample, and adaptive approaches

  • Author and own Statistical Analysis Plans (SAPs)

  • Develop custom, defensible methodology when off-the-shelf approaches won't withstand FDA scrutiny

  • Interpret results and frame them for both technical and non-technical audiences

Regulatory & Client-Facing:

  • Contribute to regulatory submissions across 510(k), De Novo, and PMA pathways

  • Participate in and help prepare for FDA interactions

  • Client meetings: introductory calls, FDA meetings, study updates, and strategic discussions

  • Internal project discussions and stand-ups as needed

Programming (supporting):

  • Direct and review programming deliverables, ensuring outputs support the statistical and regulatory strategy

  • Hands-on willingness to support and learn SAS/R programming as needed: expected to be able to step in or pick it back up, though day-to-day production programming can be delegated or shared

Administrative:

  • Time tracking for billing, logged sub-hourly against specific client engagements

  • Learning from Senior Biostat positions

What Success Looks Like

  • Statistical work that holds up under FDA scrutiny and supports client submission timelines

  • Clear, accurate communication of complex statistical concepts to both technical and non-technical stakeholders

  • Reliable collaboration across concurrent client engagements with varying scope and complexity

  • A willingness to go above and beyond in the quality of output

  • Measurable growth in regulatory knowledge over the engagement: increasingly able to handle SAP development, study design, and FDA pathway questions with less oversight

  • Proactively seeks out and applies feedback, showing a clear upward trajectory in independence and regulatory judgment

  • Taking initiative to strengthen an analysis, flag risks early, or improve a deliverable beyond the minimum ask

Qualifications

  • M.S. or Ph.D. in Biostatistics, Statistics, or a related quantitative field

  • Experience with clinical trial design, statistical analysis plans, and/or regulatory submissions (medical device/biologics experience a strong plus)

  • High Proficiency in SAS and R

  • Familiarity with FDA regulatory pathways (510(k), De Novo, PMA) preferred

  • Strong written and verbal communication skills, with the ability to translate statistical findings for non-statistician audiences

  • Comfortable managing multiple concurrent projects in a fast-paced, client-facing environment on non-standard designs and complex evidentiary packages

  • Demonstrated eagerness and ability to learn, particularly to deepen regulatory expertise over the course of the engagement

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