Associate Director of Statistical Programming with 14 years of SAS programming experience in the pharmaceutical industry for various therapeutic areas. Experienced in programming and submissions for IND, Phase 1-Phase 4, NDA, ISS, and ISE for indications including migraine headaches, chronic dry eye, non-small cell lung cancer, ulcerative colitis, Crohn’s disease, pouchitis, psoriasis, diabetes, hypercholesterolemia, and sexual dysfunction. Well versed in CDISC theory and application for electronic submission of clinical trial data. Specific areas of clinical expertise include programming to produce analysis datasets, data listings, summary tables, figures and database edit checks in addition to ad hoc programming for multiple departments and purposes. Additional areas of expertise are protocol review, CRF review (paper based as well as EDC), in-house database design review, edit check specification review, statistical analysis plan review, and quality assurance of biostatistical output and databases. Well versed in industry standards as well as the latest developments in SAS software as they impact statistical services and submissions. Excellent written and verbal communication skills. Excel in task-oriented team development displaying exemplary interpersonal skills. Strong leadership, project management and problem solving abilities. Consistent in developing and executing sound action plans.

Senior Programmer Analyst for the department of Biometrics (formerly Biostatistics). Responsibilities included creating analysis datasets, providing listings, tables, figures for various stages of clinical studies, IND submissions, NDA preparation, and periodic safety reviews using SAS software. Additional contributions to Isis clinical study development were protocol review, CRF review (paper based as well as EDC), in-house database design review, edit check specification review, statistical analysis plan review, QA of interdepartmental programming, documentation of matters concerning assigned studies, ad hoc programming upon request. Assisted in the Biostatistics SOP review process. Lead developer of Antisense Integrated Safety Database (ISDB).

Programmer Analyst in the department of Biostatistics and Data Management. Provided programming support for data summaries, reports and listings required for the development of new products (Phase I- Phase IV Clinical Trials /ISS/ISE). Provided quality assurance of programming, databases, standardization related programming, listing and statistical table output.