Associate Director, Biostatistics & AI/Data Science - Remote
Our client is an established biotech whose latest need is for an Associate Director, Biostatistics & AI to combine pharmaceutical statistical expertise with artificial intelligence and machine learning (AI/ML) to improve clinical development workflows. This role will support clinical trial design, statistical analysis, regulatory submissions, and the development of AI-powered tools that automate processes, improve data quality, and increase efficiency. You will also help ensure AI solutions meet applicable pharmaceutical quality, compliance, and regulatory requirements.
***Please Note: We welcome candidates from either a pharmaceutical biostatistics background with applied AI experience or an AI/ML engineering background with exposure to clinical or life sciences data.
Key Responsibilities
- Support statistical design, analysis, and reporting for Phase IIIV clinical trials and regulatory submissions.
- Develop and implement AI-powered tools to automate statistical programming, reporting, data quality checks, and regulatory documentation.
- Build, test, validate, and monitor AI/ML solutions in a GxP-compliant environment.
- Ensure AI tools follow applicable regulatory, documentation, and governance requirements.
- Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, IT, and external vendors.
- Oversee CRO statisticians and programmers on assigned programs.
- Develop SOPs and best practices for statistical analysis, programming, and AI implementation.
Qualifications
Candidates should hold a PhD or Masters degree in Biostatistics, Statistics, Computer Science, AI, Data Science, or a related field and meet the requirements of one of the following pathways.
Pathway A: Biostatistics-Focused
- 5+ years of pharmaceutical biostatistics experience with a PhD, or 7+ years with a Masters degree.
- Advanced SAS and/or R skills, with working knowledge of Python.
- Experience with clinical trials, CDISC standards, and regulatory submissions.
- Exposure to AI/ML tools and a strong interest in expanding AI capabilities.
Pathway B: AI/ML-Focused
- 3+ years of hands-on AI/ML engineering experience.
- Strong Python skills and experience with LLMs, RAG pipelines, AI workflows, or MLOps.
- Exposure to clinical or life sciences data and familiarity with statistical concepts.
- Working knowledge of SAS and/or R and an interest in pharmaceutical development.
All Candidates
- Strong communication, collaboration, and problem-solving skills.
- Understanding of applicable statistical and regulatory principles relevant to their background.
- A proactive approach to building and implementing AI-powered solutions in a regulated environment.
If you are interested to learn more, please send me a message to sdevine@penfieldsearch.com!