Job Title: Sr. Level SAS Programmer Location: Cupertino, CA Duration: 6+ months Visa: EAD / US Citizen/Green Card Holder Must be very senior 10+ years.
MAIN DUTIES AND RESPONSIBILITIES: Statistical programming to support ISE/ISS, ad-hoc analyses requested by medical/PK team for preNDA meeting and NDA submission, Independent validation of analysis files and key Tables/Figures produced by CRO (Contract Research Organization), including resolution of discrepancies in a timely manner, Validate that SDTM/AdAM specifications and data files for key studies meeting the submission requirements as outlined in cDISC guidelines Ensure the edit check specification and data quality for on-going clinical study Job Experience At least 5 years of Biopharmaceutical or CRO experience. Regulatory submission (NDA/BLA) experience. Fluent in SAS programming is mandatory, particularly in CDISC/SDTM Must have previous experience filing eCTD drug registration with FDA Familiarity with the preparation of regulatory documents such as Integrated Safety Summary and Integrated Summary of Efficacy is required. Skills/Competencies Excellent verbal and written communication skills. Collaborative skills in team settings are required. Must be able to work independently and be proactively resourceful Regards, Scott Robinson - IT Recruiter Direct: 609-614-0592 ITBrainiac Inc Email ID : [email protected], [email protected] www.itbrainiac.com -- You received this message because you are subscribed to the Google Groups "Open Source J2EE frameworks" 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/open-source-j2ee-frameworks?hl=en.
