Clinical Lead SAS Programmer Jobs USA
Responsibilities:
*Act as Lead Project Statistical Programmer
*Ensures timely creation of submission data/analysis documentation package according to regulatory guidelines.
*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 .
*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
(Real Staffing Group acts as an Employment Agency and an Employment Business)