Associate Director Biostatistics - -AI/Biostat (Remote)

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Job summary

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.

Qualifications

• 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

Responsibilities

• 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.

Skills

Biostatistics

AI/ML Engineering

SAS

R

Python

Education

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

Tools

SAS

R

Python

Job description

Associate Director, Biostatistics & AI

Location: Remote - USA (Occasional Travel)

Position Overview

We are seeking an Associate Director, Biostatistics & AI to support clinical development through advanced statistical analysis and the implementation of AI/ML solutions within biometrics. This role combines pharmaceutical biostatistics with applied AI technology to improve efficiency, data quality, and regulatory compliance.

Key Responsibilities

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

Qualifications

• PhD or Master's degree in Biostatistics, Statistics, Computer Science, AI, Data Science, or related field.
• Experience in one of the following areas: Biostatistics: 5+ years (PhD) or 7+ years (Master's) in pharmaceutical biostatistics, with strong SAS/R skills, Python familiarity, and exposure to AI/ML tools.
• AI/ML Engineering: 3+ years developing and deploying AI/ML solutions, including LLMs, RAG pipelines, or MLOps, with strong Python skills and exposure to clinical or life sciences data.
• Knowledge of clinical trial methodology, regulatory requirements (FDA, EMA, ICH), and applicable data standards.
• Familiarity with CDISC standards, GxP environments, and regulatory submission processes.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Demonstrated initiative in developing and implementing AI-powered solutions.