About the position
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Statistical Programmer to join our team. The Statistical Programmer will be responsible for designing, implementing, and maintaining clinical data programming solutions to support our complex Phase 1, pivotal/registrational, and long-term follow-up trials. This role will work closely with Medical, Clinical Science, Clinical Data Management, Regulatory, and Biostats teams to ensure efficient data processing, reporting, and compliance with regulatory standards. The role will report to medical in the short term with potential to report to biostatistical lead in the mid-term. A team player with a sense of urgency will thrive in this role. This is an on-site role with some hybrid flexibility.
Responsibilities
- Develop, validate, and maintain SAS or R programs for clinical data analysis and reporting (Python is also acceptable)
- Ability to generate tables, listings, and figures (TLFs) for clinical study reports (CSRs), regulatory submissions, and external publications
- Working knowledge of biostatistics including descriptive statistics, survival analysis, Kaplan-Meier methods, Cox proportional hazards models; possibility to cross-function as both programmer and biostatistician with growing team
- Support data integration, cleaning, and transformation for clinical trials, ensuring accuracy and consistency across studies.
- Develop custom scripts and macros to automate repetitive data processing tasks; flexibility to respond to ad hoc requests
- Collaborate with Clinical Data Management to create and validate edit checks and data listings for trial data quality control.
- Assist in the development of electronic data capture (EDC) systems and integrate external data sources (e.g., translational, PK(CK)/PD data, manufacturing data).
- Maintain compliance with regulatory requirements (FDA, EMA, ICH-GCP) and CDISC standards (SDTM, ADaM); work closely with clinical quality to ensure these are met
- Support programming needs for long-term follow-up studies, ensuring seamless tracking and integration of patient data over extended periods.
- Participate in regulatory inspections and audits by preparing documentation and responding to data integrity inquiries.
- Flexibility to work independently, with external biostatistical consulting groups, and/or CRO partners
Requirements
- Bachelors or Masters degree in Computer Science, Biostatistics, Data Science, Life Sciences, or related field.
- 2+ years of experience in clinical trial programming (biotech, pharmaceutical, or CRO setting preferred).
- Proficiency in SAS or R for data manipulation and statistical programming (python also acceptable)
- Experience with clinical databases, EDC systems (Medidata Rave, Oracle InForm, Veeva Vault, etc.).
- Knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
- Familiarity with cloud-based computing (AWS, Azure, GCP) and data visualization tools (Spotfire, Tableau, Shiny, etc.) as well as interest and knowledge in cutting-edge data visualization methods is a plus.
- Strong understanding of GCP, ICH guidelines, and regulatory compliance.
- Ability to work quickly, independently and with a team, with attention to detail is a must.
Nice-to-haves
- Preferred experience with cell therapy and/or oncology/bone marrow transplant trials.
- Exceptional candidates should apply, even if all criteria are not met.
