Sr. Analyst, Statistical Programming

Role Responsibilities:

• Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
• Author CDISC ADaM analysis data set specifications; identify potential data issues and define/document programming endpoint algorithms.
• Manage end-to-end programming from CRF collections through electronic submission, including preparation of electronic submission components; ensure compliance to submission standards with SMEs.
• Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead/manager on issues and resource needs.
• Verify program consistency and usage of data, analysis, and submission standards.
• Inform project team members of programming requirements, deliverable status, and resource needs.

• Bachelor’s degree.
• 5+ years relevant work experience in data management and analysis.
• 5+ years SAS Base programming with 5+ years using SAS STAT, GRAPH, and MACRO.
• 5+ years relevant industry experience.
• 5+ years clinical trial experience.
• 3+ years clinical database experience.
• CDISC and/or submissions experience.
• Knowledge of drug development process and clinical trials.
• Knowledge of drug submission requirements and relevant ICH and FDA/EMEA/ROW guidelines.
• Some familiarity with UNIX and software development packages (R, imaging, and genomics software).

• Base compensation range: $95,000.00–$.
• Medical, Dental, Vision, Life; fitness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown; paid holidays and personal days; sick time; maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year;
  Employee Resource Groups participation.