Description
New Contract Opportunity!!Clinical SAS Programmers
Mid-Size CRO
Pennsylvania, PA
12 month contract
Responsibilities:
*Act as Lead Project Statistical Programmer
*Ensures timely creation of submission data/analysis documentation package according to regulatory guidelines.
*Contribute to the creation, quality, implementation, and timeliness of the Statistical Programming and Submission Support deliverables.
*Oversee and ensure timely completion of programming for all tables, listings, and graphs .
*Participate as a team member in IND/NDA activities.
*Ensure SAS validation procedures are followed .
*Contribute to and review documents for assigned studies e.g., protocol, CRFs, Statistical Analysis Plans, Project / Integrated Analysis plans for Phase I-IV clinical studies .
*Establish, maintain, and perform quality control, and produce documentation of study clinical data bases from hand-over from Data Management up to hand-over to regulatory function, in accordance with study evaluation and clinical summary requirements .
*Transform of acquisition data delivered by Data Management to analysis data sets for statistical evaluation .
*Program the transformation of analysis data sets to submission data format for health authorities, provide respective documentation .
*Provide accurate and timely creation of submission data sets, submission program code and corresponding documentation to support electronic submissions to regulatory authorities for marketing approval .
Requirements:
*BS/MS in Statistics, Mathematics, Computer Science or equivalent
*3-5 years of pharmaceutical experience in clinical programming
*3-5 years statistical programming SAS in Pharma or Biotech
*Thorough understanding of good programming practices and methodology
*Good understanding of health authority regulations and guidelines regarding programming and computer system validation
APPLY TODAY, referrals are welcome. High visibility position. Don't miss this opportunity. Send me your resume ASAP.
Call or email me for more details. Check out my Linkedin Profile, search for Paul Dai.
Thanks
Paul
To find out more about Real please visit www.realstaffing.com