Senior Statistical Programmer

Job Advertised by Pharmadiversity Job Board - * Perform role of primary and validation statistical programmer on all assigned studies, integrated summaries, and in support of responses to questions from regulatory authorities. * Create derived data set specifications for all assigned studies and integrated summaries. * Create data definition tables for analysis data sets for all assigned studies and * integrated summaries. * Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician. * Review annotated case report forms and provide comments to study designer. * Represent Statistical Programming on all assigned project and study teams as needed. * Function in a project leader role by coordinating study team(s) and project team(s) involving other members of Statistical Programming. * Support functional service provider (FSP) model and provide statistical programming oversight and training to CROs as required for assigned studies. Oversee timelines, training, work assignments, and check quality of work performed * Support direct supervisor and Statistical Programming management. * Provide statistical programming expertise with respect to Statistical Programming, Biostatistics, and Clinical Data Management. * Maintains statistical programming binder/ebinder for assigned studies and integrated summaries. * Provide training, technical assistance, and mentoring to new statistical programmers and mentor junior statistical programmers as needed. * May review and author standard operating procedures and training guidances related to Statistical Programming processes. * Contribute to process improvement initiatives as assigned. * Perform reviews of partner databases and data sets as part of due diligence efforts as needed. * May be assigned to perform the role of Randomization Code administrator (RCA) for studies. * Bachelor's Degree in Statistics, Biostatistics, Mathematics, Computer Science, or another related field * 3-5 years experience performing statistical programming with SAS in a pharmaceutical or CRO environment * NDA submission experience preferred * Experience working with CROs preferred * Knowledge of clinical trial methodologies, drug development, and FDA GCP/ICH regulatory guidelines regarding statistical programming * Knowledge of SAS computer package and Unix * Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat * Must possess excellent skill/ability in the following: * Oral and Written Communication * Organizing * Decision Making, Judgment, and Problem Solving * People Relationships, Team Building, and Influencing Others * Initiative and Accountability * Process Improvement * Planning/Project management skill/ability preferred * Mentoring and Training new employees is preferred * Ability to respond well under aggressive time constraints * Ability to manage changing priorities/crisis management. br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=570984&tag=aje