Statistical Programmer

Position Summary:

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:

• Bachelor’s or Master’s 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.
• Preferred experience with cell therapy and/or oncology/bone marrow transplant trials.
• Exceptional candidates should apply, even if all criteria are not met.

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

Recruitment & Staffing Agencies

TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.