Biostatistician

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.

Responsibilities

• Contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs.
• Work on projects ranging from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.

Requirements

• Quantitative skills in biostatistics and clinical research.
• Experience with regulatory submissions and FDA interactions.
• Strong understanding of statistical methods relevant to medical devices and life sciences.
• Ability to work independently and collaboratively with cross-functional teams.
• Excellent communication and presentation skills.

Qualifications

• PhD in Biostatistics, Statistics, or a related field.
• At least 5 years of experience in biostatistics or related field.
• Experience in medical device or life science regulatory consulting preferred.

Skills

• Statistical programming languages (R, SAS, Python).
• Knowledge of regulatory guidelines and standards (e.g., ICH, FDA).
• Experience with clinical trial data management systems (e.g., EDC).

Benefits

• Competitive salary commensurate with experience.
• Flexible working hours.
• Professional development opportunities.
• Health insurance benefits.

Pay

Competitive salary commensurate with experience.

Schedule

Flexible working hours.