Principal Statistical Programmer
ImmunityBio, Inc.
June 26, 2026
Remote friendly (California, United States)
United States
Clinical Research and Development
Position Summary
Principal Statistical Programmer / CDISC SDTM specialist providing technical oversight and quality for statistical programming of clinical trial data; leads CDISC submission topics, process improvements, and mentors junior staff.
Essential Functions
- Lead statistical programming activities and efficient programming techniques.
- Create/validate/maintain analysis datasets and statistical outputs (traceability, reproducibility, reproducibility).
- Review/create statistical analysis plans and analysis dataset specifications; prepare electronic regulatory submissions.
- Develop and validate CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
- Lead/support data standardization (CRF/database design, edit checks, standard programs, presentations; CDISC SDTM/ADaM; e-submissions) and communicate e-submission requirements with regulators.
- Participate on clinical development and regulatory submission teams.
- Solve complex statistical programming tasks; manage study electronic subdirectories.
- Design/create/validate global programming macros.
- Plan and budget resources; anticipate long-term resource needs.
- Develop/revise processes; stay current on programming techniques.
- Provide guidance/mentoring and SOP adherence; improve templates/standardization.
Education & Experience
- BS (Stats/Biostats/CS/Math or related) + 10+ years, OR MS + 8+ years.
- 5+ years pharma statistical programmer experience (preferred).
- Expert in CDISC STDM and SDTM regulatory deliverables.
- Lead statistical programmer experience on multiple concurrent projects.
Knowledge/Skills
- Clinical research, GCP, and regulatory requirements.
- Strong statistical programming; highly proficient in SAS; excellent English communication.
Benefits (eligible employees)
- Medical, dental, vision; wellness programs; EAP; life/AD&D, disability; FSA; 401(k) match; 529; PTO (11 holidays for exempt/unlimited for exempt/outlined vacation for non-exempt).
Principal Statistical Programmer / CDISC SDTM specialist providing technical oversight and quality for statistical programming of clinical trial data; leads CDISC submission topics, process improvements, and mentors junior staff.
Essential Functions
- Lead statistical programming activities and efficient programming techniques.
- Create/validate/maintain analysis datasets and statistical outputs (traceability, reproducibility, reproducibility).
- Review/create statistical analysis plans and analysis dataset specifications; prepare electronic regulatory submissions.
- Develop and validate CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
- Lead/support data standardization (CRF/database design, edit checks, standard programs, presentations; CDISC SDTM/ADaM; e-submissions) and communicate e-submission requirements with regulators.
- Participate on clinical development and regulatory submission teams.
- Solve complex statistical programming tasks; manage study electronic subdirectories.
- Design/create/validate global programming macros.
- Plan and budget resources; anticipate long-term resource needs.
- Develop/revise processes; stay current on programming techniques.
- Provide guidance/mentoring and SOP adherence; improve templates/standardization.
Education & Experience
- BS (Stats/Biostats/CS/Math or related) + 10+ years, OR MS + 8+ years.
- 5+ years pharma statistical programmer experience (preferred).
- Expert in CDISC STDM and SDTM regulatory deliverables.
- Lead statistical programmer experience on multiple concurrent projects.
Knowledge/Skills
- Clinical research, GCP, and regulatory requirements.
- Strong statistical programming; highly proficient in SAS; excellent English communication.
Benefits (eligible employees)
- Medical, dental, vision; wellness programs; EAP; life/AD&D, disability; FSA; 401(k) match; 529; PTO (11 holidays for exempt/unlimited for exempt/outlined vacation for non-exempt).