IMMEDIATE NEED - Sr. Level SAS Programmer * Must be very senior 10+ years. *
* Send Resumes To [email protected] * Visa: EAD / US Citizen/Green Card Holder Job Title: Sr. Level SAS Programmer Location: Cupertino, CA Duration: 6+ months Visa: EAD / US Citizen/Green Card Holder 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 * Send Resumes To [email protected]* Regards, John Smith - IT Recruiter ITBrainiac Inc Direct: 646-300-9924 [email protected] -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" 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/citrix-and-sap-problems?hl=en.
