[itroundtable] LEAD: SAS Programmer - NJ - 11 mos gig

Position         : SAS Programmer Location        : Pine Brook, NJ Duration       : 11+ Months   Description   Responsibilities: The contractor will be responsible for implementing solutions for two high priority projects, OSI listings and Medicare Reporting. OSI listings are data listings required with FDA submissions, for pivotal studies. SAS ODS will be used to create detailed PDF files by subject in a specific format as defined by FDA. For the efficacy portion of the listings, the contractor will have to work with project teams to define efficacy listing specifications. Medicare Reporting involves reporting of Adverse Events and Serious Adverse Events of study subjects who are enrolled in Medicare. The contractor will be responsible for designing and implementing a system to provide on a quarterly basis all AE's and SAE's for study subjects who are enrolled in Medicare. This will involve interacting with an external company to receive information about which subjects are on Medicare, and with internal Bayer coding experts who will recode the data to ICD10, as well as creating data exchange interfaces to the clinical database to retrieve the adverse event information and send it to the appropriate users. Qualifications: The incumbent must have an MS degree in a biological science, Statistics, Computer Science or a related field and at least 6 years related experience of which 5 years within the pharmaceutical industry and 4 years experience as a SAS programmer. Or a BS degree with 8 years related experience of which 5 years within the pharmaceutical industry and 4 years experience as a SAS programmer. A strong understanding of Clinical Data Management processes. Strong experience in SAS programming and ODS. Strong knowledge of database structure design, especially the CDISC SDTM data model. Strong understanding of clinical study designs. Very good understanding of data handling processes and preferably clinical study programming. Experience in designing and implementing data management process tools is a plus. Good understanding of the drug development process, including all Phases I-IV. Good understanding of regulations, standards and guidelines (e.g. ICH, GxP, CDISC, European Clinical Trials Directive, Privacy rules [HIPPA]). Familiarity with validation of systems Ability to lead projects Ability to work independently as well as part of a team environment. Ability to communicate outside of the programming group. Effective self-management and organizational skills. High commitment to quality and attention to detail. Excellent negotiation and issue management skills. Fluency in English. Excellent written and oral communication skills.   Thanks & Regards….?     Abhishek Sharma Tanisha Systems, Inc.     '. 617-963-8407 Ext 8515 '. 617-729-0260/0261  ||  6. 617-801-8880 *. Abhishek@tanishasystems.com || www.tanishasystems.com   MIS Ntwk Assoc Mtg Dates: May 22nd - Tues Reg Mtg - 6 pm - Berman Larson Kane Offices, Paramus - DO NOT use GPS for directions. Get dir from BLK site - Bring 15 copies of your resume June 5th Dinner Mtg - Abby Kohut June 12th no meeting