Senior Analyst, Statistical Programming

Responsibilities

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
• Authors CDISC (Clinical Data Interchange Standards Consortium) ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination.
• Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
• Manages the end-to-end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submissions components; works with SMEs (Subject Matter Expert) to ensure compliance to submission standards.
• Serves as the Statistical Programming Lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management and the data strategy plan.
• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

• Bachelor’s degree required
• 5+ years relevant work experience within an organization with a focus on 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, relevant ICH and FDA/EMEA/ROW guidelines
• Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)