About the Role

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.

• 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.