Title: Statistical Programmer Location: Pine Brook, NJ ( Best to be a Local ) Duration: Long Term Pay: DOE Interview Type: Telephonic + Skype Seats Required: 3
Required: Statistical Programmer with 7-15+ years experience supporting clinical trials in the Pharmaceutical industry Strong drug development background experience programming all phases of clinical trials, with significant NDA/submission experience NDA submission experience is REQUIRED Oncology experience a plus Strong technical SAS programming skills required familiarity with CDISC SDTM and ADaM project management experience Title: SAS Programmer Location: Pine Brook, NJ Duration: Long Term Pay: DOE Interview Type: Phone + Skype Required: 5 to 7 years of SAS programming experience within the Pharmaceutical industry supporting clinical trials, for example, working within the Data Management or Biostatistics functions Extensive knowledge of CDISC SDTM data structures Prior knowledge and experience of mapping of clinical trial data from legacy standards into conformant and compliant CDISC SDTM version 3.1.2 domains Knowledge and experience of performing validation. Knowledge of WebSDM, OpenCDISC checker or similar tools is a plus. SDTM submission experience is a plus Knowledge of the define.xml is a plus Role Discription: Working on 8 different FDA submissions during 2012, the contractor will be required to perform validation/acceptance of mapped clinical trials data from legacy standards into conformant and compliant CDISC SDTM version 3.1.2 domains. The contractor will use various validation techniques to confirm all data were mapped correctly and consistently. WebSDM will also be used to check for conformance to SDTM 3.1.2. Depending on the specific submission, the contractor will work either within a team or individually to perform the validation. A vendor will be assigned to perform the mapping of the data so direct communication/feedback to the assigned vendor will be required. Additionally, the contractor will support the mapping exercise for a FDA information request – this will require 10 domains for 6 studies to be mapped to SDTM+ format and will be managed jointly with assigned programmers from the Biostats department. Submissions to be supported include: Radium-223, Xarelto VTE, Regorafenib GIST, FC Patch, Florbetaben, Sorafenib Thyroid, Gadovist Breast and Riociguat PHIMS Title: Database Developer Location: KS Duration: Long Term Pay: DOE Interview Type: Telephonic + F2F Required: EXPERIENCE IN A PHARMA/BIO COMPANY Expert level MS SQL (T-SQL) programming skills and basic VB programming skills. 7+ years experience Must understand jobs, stored procedures, views, functions, SSIS packages and VB Scripts Prefer candidates with intermediate experience using ASP.Net, C#.Net Send Resumes to [email protected] David Benzimen 732-665-6246!! 732 231 7458 [email protected] -- You received this message because you are subscribed to the Google Groups "SureIT" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/sureITlife?hl=en.

