Principal Statistical Programmer Consultant
Core
Lead statistical programming for solid tumor oncology clinical trials, developing datasets and reports for regulatory submissions.
Role type
Principal Statistical Programmer Consultant (Clinical CRO)
Builds
SDTM/ADaM datasets, TFLs, and statistical outputs for Phase I–III oncology studies
Domain
Clinical Research / Oncology / Biostatistics
Required skills
SAS programming (Base, Macro, STAT), CDISC SDTM/ADaM standards, time-to-event analysis (Kaplan-Meier, Cox models), solid tumor oncology endpoints (OS, PFS, ORR, DoR, DCR), regulatory submission support (FDA/EMA), technical leadership
Preferred skills
Immuno-oncology experience, targeted cancer therapies, specific solid tumor indications (head and neck, lung, colorectal, breast), prior technical leadership/mentoring
Technologies
SAS, CDISC standards
Responsibilities
Lead statistical programming activities for oncology 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