Principal Statistical Programmer

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). #J-18808-Ljbffr