Principal Statistical Programmer Consultant – Oncology (Solid Tumors)-Remote
Core
Lead statistical programming for solid tumor oncology clinical trials, developing datasets and reports for regulatory submissions.
Role type
Principal Statistical Programmer (Oncology)
Builds
SDTM/ADaM datasets, TFLs, and statistical outputs for Phase I–III clinical study reports
Domain
Clinical Research / Oncology / Biostatistics
Required skills
SAS programming (Base, Macro, STAT), CDISC SDTM/ADaM standards, time-to-event analysis (Kaplan-Meier, Cox models), oncology endpoint analysis (OS, PFS, ORR, DoR, DCR), regulatory submission support
Preferred skills
Immuno-oncology experience, targeted cancer therapies, FDA/EMA submission experience, team mentorship
Technologies
SAS, CDISC
Responsibilities
Lead statistical programming activities for solid tumor trials; Develop and validate SDTM/ADaM datasets; Program complex TFLs for clinical study reports; Support efficacy and safety analyses; Provide technical leadership and mentorship to programming teams; Review programming specifications and outputs for accuracy
Seniority
Principal, hands-on IC with leadership
