Principal Statistical Programmer
Core
Senior technical expert developing, validating, and delivering high-quality SAS programming deliverables for clinical trial analysis and regulatory submissions.
Role type
Principal Statistical Programmer (Individual Contributor)
Builds
CDISC-compliant SDTM/ADaM datasets, TLFs, Define.xml, and reviewer guides for oncology clinical trials
Domain
Clinical trials / Oncology / Biostatistics
Required skills
SAS programming, CDISC standards (SDTM, ADaM, CDASH), regulatory submission experience, data validation, macro development, cross-functional collaboration
Preferred skills
NDA submission experience, Oncology/Hematology domain knowledge, Pinnacle 21 proficiency
Technologies
SAS, Pinnacle 21, EDC systems, MS Office suite
Responsibilities
Develop and validate CDISC-compliant datasets and regulatory deliverables; Provide hands-on SAS programming for key analyses; Collaborate with Biostatistics and Data Management teams; Lead technical initiatives for SAS macros and reusable tools; Review data management plans and validation documentation.
Seniority
Principal, hands-on IC
