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.

• 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.

• 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.