IMMEDIATE NEED - Sr. Level SAS Programmer
* Must be very senior 10+ years.
*
* Send Resumes To j...@itbtalent.com
*
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 j...@itbtalent.com*
Regards,
John Smith - IT Recruiter
ITBrainiac Inc
Direct: 646-300-9924
j...@itbtalent.com
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