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IT Elite Inc is looking for Senior Lead / Sr. SAS Clinical Programmer to work on a long term assignment with our client.

Remote & W-2 opportunity.



Qualifications:


· 12-15+ years of Statistical SAS Programming experience within the life science industry, preferably on the Sponsor side

· These consultants will need to be a experienced lead programmers with excellent organization and planning skills.

· They must also have ISS/ISE experience and understand integrations

· Must have recent experience as a Lead for assigned studies and

· Must have management experience including oversight, work assignment and productivity management of other programmers

· Needs to understand complex studies and have end-to-end regulatory submissions experience

· Safety and efficacy experience (ISS/ISE) is required

· Must have experience performing data manipulation, analysis and reporting of clinical trial data

· Strong knowledge of CDISC (must be skilled with both SDTM & ADaM)

· Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines



Responsibilities:



· They will not only be assigned as the FSP leads overseeing other programmers' work/timelines/productivity, but will also be strong hands-on contributors to the team driving the end-to-end regulatory submission

· Reporting to a client FTE manager, will work in client system and processes as the functional programming workstream FSP lead responsible for trial deliverables

· Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed

· Participate in hiring and onboarding of operational FSP programmers

· Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs

· Perform validation and QC of the programs, datasets and statistical reports per study requirements

· Authors SDTM and ADaM dataset specifications including the identification of potential data issues or areas of critical data examination

· Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components

· Other related programming activities



If your skills match the above requirement, Please forward your resume as a word attachment along with your contact numbers and salary requirements.



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