Role: Principal SAS ProgrammerResponsibilities:
Duration: 12 Months Contract
Interview: Telephonic + Face to Face
Work with Statistician/CROs to ensure the quality of deliverables TFLs, create/validate SDTM/ADaM specs and QC SDTM mapping/ ADaM datasets / TFLs.
Provide in-house programming supports such as ad-hoc analysis, CSR programming, regulatory filings, publication requests.
Contribute to develop/validate SAS programming of endpoints based on RECIST criteria.
Review clinical study documents including CRF design/Annotation, SDTM specs, and edit checks and contribute to data cleaning process.
Support creation and validation of esubmission requirements (i.e. annotated CRF, data export files, define documents).
Contribute to SOP development for programming and validation process, in-house infrastructure of programming (folder structure/Data achieving/Central File Maintenance. )
Contribute to develop SAS programming standard templates of ADaM/TFLs and other statistical documents.
Contribute to data pooling of integrated summary of Safety (ISS) / Efficacy (ISE).Qualifications:Skills:
Familiar with SDTM, ADaM, and CDISC/eSub requirements for regulatory submissions.
Expertise in SAS programming/Macro development.
Experience with data pooling to support Integrated Summary of Safety (ISS) / Efficacy (ISE) preferred.
Ability of handle multiple tasks with multiple timelines.
Excellent inter-personal skills in management, collaboration and communication internally and externally.
Management Experience as coordinating programming activities.
MS with seven years experience including industry background.
Oncology experience preferred.
Have a nice day.
Thanks and Regards,
Sainath Pantar Solutions Inc Direct: O : EXT- 208 Email: Sainath@pantarsolutions.com112 South Tryon St., Suite 755 Charlotte, NC 28284 USA
SAS Programmer/Manager, Drug development, Clinical SAS, Clinical trials