- Company Name
- Novartis
- Job Title
- Senior Principal Data Scientist
- Job Description
-
**Job Title:** Senior Principal Data Scientist
**Role Summary:**
Lead data science strategy and execution for clinical development programs, integrating multimodal patient‑level data (biomarkers, genomics, proteomics, clinical outcomes) with advanced statistical and AI methods to influence drug development decisions and regulatory submissions. Drive cross‑functional collaboration, mentor emerging teams, and manage project budgets and timelines.
**Expectations:**
- Deliver high‑impact data science solutions that streamline development and support regulatory submissions.
- Provide technical and scientific leadership in biomarker‑driven AI analyses.
- Communicate findings through presentations, visualizations, and scientific narratives.
- Manage project scope, resources, and budgets while ensuring compliance with regulatory and internal standards.
**Key Responsibilities:**
1. Design, implement, and validate exploratory biomarker and AI analyses for low‑to‑mid complexity clinical programs.
2. Integrate heterogeneous data (clinical, real‑world, omics) to generate actionable evidence for drug development decisions.
3. Contribute scientific content to decision‑making documents (briefing books, trial designs, regulatory responses).
4. Collaborate with analytics, pharmacometric, data management, and cross‑functional teams to align biomarker/AI strategies.
5. Mentor junior scientists and, when applicable, lead a small project team, overseeing staff allocation and performance.
6. Maintain robust project governance, including budget tracking, risk assessment, and milestone reporting.
**Required Skills:**
- Advanced statistical expertise (time‑to‑event, mixed‑effects, longitudinal, Bayesian, meta‑analysis).
- Proficiency in machine learning (supervised, unsupervised, variable selection, deep learning) and high‑dimensional data handling.
- Strong programming skills (Python/R, SQL).
- Knowledge of clinical trial design, biostatistics, and GxP data practices.
- Experience with genomics/omics data analysis and high‑dimensional biomarker platforms.
- Excellent communication and storytelling skills for non‑technical audiences.
- Leadership and project management capabilities, including budget oversight.
**Required Education & Certifications:**
- Ph.D. or equivalent in Data Science, Biostatistics, Bioinformatics, Pharmacology, Mathematics, or a closely related quantitative field.
- Minimum 3 years of experience in pre‑clinical and clinical drug development with comprehensive exposure to clinical trials.
- Domain expertise in at least one therapeutic area and understanding of clinical study design principles.
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