TScan Therapeutics is seeking a Clinical Scientist to design, execute, and analyze clinical trials for cell therapy treatments.
Requirements
- Expertise in R, Python, or SAS for data analysis, machine learning, and statistical modeling.
- Experience working with bone marrow transplant, hematologic malignancies, or cell therapy clinical trials.
- Knowledge of real-world evidence (RWE) generation, registry data, and biomarker-driven analytics.
- Experience with electronic data capture (EDC) systems such as Medidata Rave, Oracle InForm, or Veeva Vault.
- Strong understanding of GCP, ICH guidelines, CDISC (SDTM, ADaM), and regulatory compliance.
- Ability to develop and apply statistical models, machine learning, and AI-driven analytics to clinical trial and real-world data.
- Knowledge and ability to visualize complex data using most up-to-date methods.
Responsibilities
- Assist in the design and development of clinical trial protocols, investigator brochures, and clinical development plans.
- Support the execution of Phase 1 through registrational and long-term follow-up trials, ensuring adherence to regulatory and scientific standards.
- Analyze clinical trial data and contribute to the interpretation of efficacy and safety results and ongoing trial optimization.
- Support regulatory submissions (INDs, BLAs, NDAs, and MAAs) by preparing clinical data summaries and responses to regulatory authorities (FDA, EMA, etc.).
- Develop predictive algorithms for GvHD risk, relapse, and transplant-related mortality (TRM) in cell therapy and bone marrow transplant patients.
- Collaborate with data management and programming to ensure accurate data cleaning, transformation, and mapping to CDISC standards (SDTM, ADaM).
- Develop interactive dashboards (e.g., using Python, R, Tableau, or Spotfire) for real-time clinical data monitoring.
Other
- Master’s w/ 7+ or Ph.D. with 3+ or equivalent in Data Science, Biostatistics, Immunology, Computational Biology, Epidemiology, or a related field
- 3-5+ years of experience in clinical data science, clinical development, biostatistics, or clinical analytics in the biotech, pharma, or CRO industry.
- Ability to work independently in a fast-paced biotech environment while collaborating cross-functionally.
