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Role Overview
As Senior Principal Biostatistician, you provide high-level statistical leadership across clinical development. You guide study design, analysis, interpretation, and regulatory deliverables, mentor statisticians, and collaborate across functions to ensure scientific rigor and high-quality evidence for global regulatory authorities.
Key Responsibilities
Statistical Leadership
* Lead statistical strategy, methodological guidance, and study-level decision making with high autonomy.
* Oversee design, analysis, interpretation, and documentation of clinical trials.
* Ensure quality, integrity, and timeliness of statistical and programming deliverables.
* Develop and review protocols, SAPs, and CSRs.
Regulatory & Scientific Contributions
* Provide statistical input to regulatory submissions and responses.
* Represent statistical positions in interactions with FDA, EMA, and other authorities.
* Stay current with regulatory guidance and statistical methodologies.
Cross-Functional Partnership
* Work closely with clinical science, data management, medical writing, programming, and regulatory teams.
* Influence program-level decisions and support quantitative decision making.
Leadership & People Development
* Mentor statisticians and contribute to building statistical excellence within the organization.
Qualifications
Education
* Master’s degree in statistics, mathematics, data science, or another quantitative field - Required
Experience
* 10+ years as a statistician or data scientist in the pharmaceutical industry - Required
* 3+ years in a leadership or supervisory capacity - Required
* Experience with regulatory submissions and interactions with health authorities - Required
* Strong knowledge of international clinical research regulations and drug development processes - Required
* Proficiency in R - Required
* Excellent communication, prioritization, and interpersonal skills - Required
* Participation in industry groups or peer-reviewed publications - Preferred
Additional Information
* Sedentary work environment, occasional brief walking/standing
* No direct supervision but provides guidance to others
Reach out if you are interested!
Seniority level
* Associate
Employment type
* Full-time
Job function
* Other
Industries
* Pharmaceutical Manufacturing
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