Responsibilities:
Technical Architecture & Hands-On Development
- Perform statistical analysis and apply advanced statistical modeling techniques
- Design, train, and optimize machine learning and deep learning models for various business use cases
- Deploy models into production environments and ensure reliable model serving and scalability
- Build and maintain robust GxP-compliant ML pipelines on cloud infrastructure (AWS/Azure/GCP) including data ingestion, preprocessing, training, and monitoring
- Evaluate model performance using appropriate metrics and continuously improve accuracy and efficiency
- Collaborate with cross-functional teams (engineering, product, and business stakeholders) to translate requirements into data-driven solutions
- Monitor deployed models for performance drift and retrain models as necessary
- Ensure best practices in model versioning, reproducibility, and documentation
- Conduct hands-on code reviews, architectural reviews, and model performance evaluations for all team deliverables.
People Leadership & Team Development
- Directly manage and mentor a team of 4–8 ML engineers, data scientists, and data engineers with defined technical goals and OKRs.
- Set individual development plans, run performance reviews, and build a culture of technical excellence, scientific rigor, and continuous learning.
- Recruit, interview, and hire top data science and ML engineering talent with strong domain experience in life sciences or regulated industries.
- Foster a collaborative environment where the team is empowered to propose, prototype, and ship novel ML solutions with speed and quality.
- Act as the technical escalation point for the team — unblocking architecture decisions, performance issues, and regulatory compliance questions.
Cross-Functional Collaboration
- Partner with the Product Manager (Data Science) to translate business and regulatory requirements into precise, implementable ML specifications.
- Collaborate with platform engineering on data infrastructure, API design, and integration of ML models into the ValGenesis SaaS platform.
- Work with the Quality and Compliance team to ensure all ML features are properly validated, documented, and audit-trail compliant under 21 CFR Part 11.
- Engage with strategic customers and key opinion leaders (KOLs) in the pharma industry to validate model approaches and gather technical feedback.
- Present technical architecture and model performance to executive leadership, customer CTOs, and regulatory affairs teams.
ML Operations & Governance
- Establish MLOps practices: model versioning, experiment tracking, automated retraining triggers, drift detection, and production monitoring.
- Define model governance standards for the GxP environment, including model qualification, change control, and periodic review procedures.
- Own the technical roadmap for the data science platform, balancing research innovation with production stability and regulatory compliance.
Requirements:
Education
- Degree in Statistics, Machine Learning, Computer Science, Biostatistics, Chemical Engineering, Pharmaceutical Sciences, or related quantitative field.
- Bachelor’s degree considered only with 8+ years of directly relevant hands-on experience.
Experience
- 5+ years of hands-on data science and ML engineering experience, with at least 3 years in a technical leadership or architect role.
- Proven track record of building and shipping production ML models at scale, not just research prototypes or POCs.
- 5+ years of experience in the pharmaceutical, biotech, or medical device industry in a technical role involving process data, quality analytics, or statistical modeling.
- Demonstrated hands-on experience building all model types listed in the Technical Skills Matrix above.
- Experience leading a team of 3+ data scientists or ML engineers with measurable outcomes.
- Experience at a life sciences SaaS company or pharmaceutical analytics vendor
- Contributions to open-source ML libraries, statistical packages, or pharmaceutical data standards (CDISC, SDTM, ADaM).
- Certified in cloud ML platforms (AWS ML Specialty, Azure Data Scientist, GCP ML Engineer).
- Six Sigma Black Belt or ASQ CQE with a strong statistical application background.