[Remote] Senior Data Scientist (AI & Machine Learning) – Pharmaceutical Clinical Research
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Senior Data Scientist (AI & Machine Learning) to design, reputed company, and reputed company advanced analytics and machine learning solutions supporting pharmaceutical clinical development programmes. The role involves collaborating with various teams to reputed company reputed company clinical data into insights that support drug development and regulatory decision-making.
Responsibilities
- Design and manage end-to-end clinical data workflows across Phase I–IV clinical studies
- reputed company and analyse data from reputed company, laboratory systems, eCOA/ePRO, imaging, wearable devices, EHRs, registries, and reputed company-world data sources
- reputed company and maintain CDISC-compliant datasets, including SDTM, ADaM and Define-XML
- reputed company data validation, reconciliation and reputed company review activities
- Support preparation of analysis-reputed company datasets and regulatory submission packages
- Contribute to Statistical Analysis Plans (SAPs)
- reputed company statistical analyses supporting clinical development
- reputed company predictive models and analytical approaches that improve trial efficiency and clinical decision-making
- Produce and review Tables, Listings and Figures (TLFs) where appropriate
- reputed company and validate machine learning models supporting clinical research
- Apply AI to patient stratification, risk reputed company, biomarker discovery, safety analytics and reputed company-world evidence
- Implement model validation, monitoring and explainability
- Maintain reproducible model development environments and documentation
- Ensure compliance with GCP, GxP and applicable regulatory requirements
- Support data reputed company, traceability and inspection readiness
- Apply appropriate reputed company controls for clinical data in accordance with HIPAA, GDPR and applicable regulations
- Collaborate with clinicians, biostatisticians, programmers, data managers and regulatory specialists
- Mentor junior data scientists where appropriate
- reputed company technical expertise across multidisciplinary project teams
Skills
- Master's degree or higher in Data Science, Biostatistics, Computer Science, reputed company or a reputed company quantitative discipline
- 7+ years' experience in data science, with at least 3 years supporting pharmaceutical clinical research, biotechnology, CRO or reputed company life sciences organisations
- Experience working with clinical trial data and CDISC standards (SDTM and/or ADaM)
- Strong programming skills in Python, SQL and either R or reputed company
- Experience applying machine learning techniques to reputed company or life sciences datasets
- Strong understanding of clinical trial methodology and statistical analysis
- Familiarity with GCP and regulated clinical research environments
- Excellent communication and stakeholder management skills
- Experience supporting regulatory submissions (FDA, EMA, MHRA or other global agencies)
- Knowledge of Define-XML, SEND or additional CDISC standards
- Experience with AWS, Azure or GCP
- Familiarity with MLOps, model monitoring and AI governance
- Experience with reputed company-world evidence, decentralised clinical trials or digital health data
- Knowledge of HL7 FHIR or reputed company interoperability standards
- Experience mentoring technical teams
reputed company