Associate Director, Biostatistics & AI (Remote)

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Health insurance

Zusammenfassung

Penfield Search Partners Ltd. seeks an Associate Director of Biostatistics & AI to advance clinical development using AI/ML within biometrics. Remote in the USA with occasional travel, collaborating across Clinical Development, Regulatory Affairs, and Medical Affairs.

The role combines biostatistics with AI to improve data quality, regulatory compliance, and efficiency, leading analyses, adaptive trial designs, and regulatory submissions while mentoring CRO statisticians.

Qualifikationen

• PhD or Master’s in Biostatistics/Statistics/CS/AI/Data Science
• Extensive pharma biostatistics experience with SAS/R and Python familiarity
• AI/ML development experience including LLMs, RAG, or MLOps
• Regulatory submission knowledge (FDA/EMA) and CDISC standards
• Strong communication and cross-functional collaboration skills

Aufgaben

• Lead statistical analysis and reporting for Phase II-IV trials with adaptive designs and Bayesian methods.
• Support NDA/BLA/MAA submissions and regulatory responses.
• Design, implement, and validate AI/ML tools integrating SAS, R, Python with clinical data systems.
• Develop AI-driven SAPs, TFL automation, data validation and regulatory documentation.
• Establish AI governance, validation, and monitoring per GxP requirements.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs and cross-functional teams.
• Oversee CRO statisticians and programmers and contribute to SOPs and best practices.

Kenntnisse

Biostatistics

AI/ML Engineering

SAS

R

Python

Ausbildung

PhD or Master's in Biostatistics/Statistics/CS/AI/Data Science

Tools

SAS

R

Python

Jobbeschreibung

Penfield Search Partners Ltd. seeks an Associate Director of Biostatistics & AI to advance clinical development using AI/ML within biometrics. Remote in the USA with occasional travel, collaborating across Clinical Development, Regulatory Affairs, and Medical Affairs.

The role combines biostatistics with AI to improve data quality, regulatory compliance, and efficiency, leading analyses, adaptive trial designs, and regulatory submissions while mentoring CRO statisticians.