STATISTICAL PROGRAMMER - CLINICAL TRIALS REQUIREMENT #12-00459 RECRUITER: BRIDGET BURNS JOB LOCATION: PARSIPPANY, NJ JULY 20, 2012 Project Description: Responsible for all aspects of statistical programming to support NDA submission Responsibilities: Manage and perform statistical programming activities, including derived datasets, tables, figures, listings, and data definition tables to support one or more product(s) through Phase I-IV clinical trials, regulatory filings, pharmacovigilance, publications, competitive strategies, and other related functional tasks Review protocols, statistical analysis plans, and case report forms, and provide SAS data specifications for clinical trials Ensure programming deliverables are consistent and comply with study protocols, statistical analysis plans, and case report forms Convert, check, and integrate multiple sources of incoming data into the creation of analysis datasets Provide programming support to the preparation of integrated reports and filing activities Perform programming validation to ensure quality of analysis datasets and programmed output Provide ad-hoc analysis programming to explore repository databases and to support publications Required: Bachelor's or preferably Master's or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics, Computer Science, Life Sciences, or related field 5+ years of pharmaceutical experience Proven experience in NDA submissions, especially creation of pooled SAS datasets for integrated analysis of safety and integrated analysis of efficacy Good interpersonal, communication, problem-solving, and analytical skills Expert technical skills in SAS Base/Macro/Graph Excellent experience in high-level efficient SAS programming Excellent knowledge of CDISC-compliant SAS data structures (SDTM, ADaM, DDT) and other related regulatory guidance Knowledge of Excel, ACCESS, and other statistical software such as S-Plus, SPSS, and etc. is a plus Work independently with minimum or none supervision Ability to collaborate and communicate with cross-functional team members Flexible and excellent ability to work on multiple studies with competing priorities This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: [Click Here to Email Your Resumé] Requirements clinical trials; NDA submissions; SAS programming