Biostatistician

Biomedical Statistical Consulting® • Philadelphia, PA

1d

About The Position

You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.

Requirements

• Biostatistics expertise
• Clinical development knowledge
• Regulatory strategy understanding
• Experience with medical device and life-science programs
• Experience with non-standard designs, external controls, or complex evidentiary challenges

Responsibilities

• Contribute to study design
• Develop statistical analysis plans
• Prepare regulatory submissions
• Engage in FDA interactions
• Shape analyses that must withstand real regulatory scrutiny

What This Job Offers

• Job Type: Full-time
• Career Level: Senior