Perform analysis of datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. Perform data manipulation, analysis and reporting of clinical trial data specifically for both safety and efficacy (ISS/ISE). Produce TLFs, outputs, reports and QCing outputs effectively using hands-on SAS Programming for creation and QC of clinical Tables, Listings and Graphs. Use SAS statistical software (and other statistical software such as JMP-Clinical, Pinnacle 21, and R). Support regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines. Perform validation and QC of the programs, datasets and statistical reports per requirements. Prepare SDTM and ADaM dataset specifications including the identification of potential data issues or areas of critical data examination. Work with Biostatistics on defining and documenting programming endpoint algorithms. Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components. Partner with Biostatistics to deliver high quality, submission ready statistical outputs.

Requirements:       

Master’s degree (or foreign equivalent) in Management Information Systems, Engineering (any), Information Technology or closely related field plus 24 months of experience in the job offered or related statistical programming analyst positions.

Must have experience with: SQL; SDTM and ADaM datasets; and SAS statistical software: SAS/BASE; SAS/STAT; SAS/MACRO; and SAS/CONNECT

Travel Required to Unanticipated Locations throughout the US.

Apply:

Recruitment – SunTechPros, Inc.

5920 S. Miami Blvd, Suite 205-B

Morrisville, NC  27560

OR

Email: resumes@suntechpros.com

Must reference “Senior Statistical Programmer Analyst” when applying.