Hi Partner, This krish from Gdn Infotech, please find the below requirement and send suitable resume with contact info.
Title --- Sr. Statistical Programmer Location ---Stamford, CT Duration --- 1 year ** PLEASE ONLY SEND CANDIDATES WITH PHARMA EXPERIENCE AND GREAT COMMUNICATION SKILLS!! Required skills :- 1. analyze data and create ad_hoc reports 2. create analysis data specifications and data sets 3. produce official tables, listings, and graphs for submission 4. pool clinical data for ISS and ISE 5. review and validate deliverables from CRO Assist with study level data and documentation preparation for submission, following FDA guidelines. Provide programming support to the BTDS re-submission team Work as a BSP member of the BTDS submission readiness team, organize, review and update, if necessary, the internal documentation for each study to make sure it follows the appropriate WPDs. Prepare the data and documentation for each of the 35 studies in the BTDS re-submission for transfer to the FDA. This will include making an inventory of all datasets for each study and preparing SAS transport files. This may include review of SAS code to update an existing DEFINE file or create a new DEFINE Assist in the validation of ISS and/or ISE analysis datasets and SAS output Assist in the writing of standard reports in SAS Requires knowledge of SAS. Experience with clinical data as well as FDA guidelines and requirements for NDA, as well as experience in assembling programming documentation for an NDA. -- Thanks and regards, Krish Kumar, Gdn Infotech 317-863-0721 [EMAIL PROTECTED] All Human powers with you, you can achive any thing do you want. --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "KNOW.IT" 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/KNOW_IT_AZ?hl=en -~----------~----~----~----~------~----~------~--~---
