Sr. Principal Analyst, Statistical Programming

What You’ll Do Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables (internal and/or vendor). Author CDISC ADaM analysis data set specifications; identify data issues and document programming endpoint algorithms (study/drug program/TA). Manage end-to-end programming from CRF collection through electronic submission, including ESUB components (reviewer’s guide input, annotated CRF, define.xml, and XPTs) and ensure eSUB compliance with SMEs. Identify and remediate process inefficiencies; train the department on new processes. Serve as Statistical Programming Lead to achieve drug program milestones; assess objectives, elevate issues, and support resource needs. Verify consistency and usage of data, analysis, and submission standards across the department. Inform internal/external project teams of programming requirements, deliverable status, and resource needs. Required Skills Bachelor’s degree required; MS/PhD in Statistics or Mathematics preferred. 10+ years relevant data management/analysis experience. 10+ years SAS Base; 7+ years SAS STAT/GRAPH/MACRO. 10+ years relevant industry and 10+ years clinical trial experience. 5+ years clinical database experience. CDISC and/or submissions experience; deep knowledge of drug development and submission requirements (ICH and FDA/EMEA/ROW). Familiarity with UNIX; R and other software development packages. Familiarity with AI/ML concepts. Benefits Medical, Dental, Vision, and Life insurances; Fitness/W wellness reimbursement. Short- and Long-Term Disability; 15+ days paid vacation plus end-of-year shutdown. Up to 12 paid holidays + personal days; sick time; paid Maternity/Parental Leave. 401(k) match; Employee stock purchase plan; Tuition reimbursement up to $10,000/year. #J-18808-Ljbffr Scorpion Therapeutics