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Sr. SAS Programmer

Job Attributes

Job Id:

13442

Job Category:

Clinical & Life Sciences

Job Location:

Silver Spring, MD  2010

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

 

Responsible for creation of SAS programs and datasets in support of Lung Biotechnology clinical trials according to SOPs and guidelines. Programmer will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. Programmer will act, as needed, in a lead position to provide direction and oversight to programmers (internal or external) for creation of applicable deliverables. The position reports to the Director of Biostatistics and Data Management.

 

 

 

  • Independently produce the SDTM and ADaM datasets and tables, listings, and figures per programming specifications, Statistical Analysis Plans, and other study related documentation
  • Participate in the structure and content review of 3rd party provided SDTM, SEND, ADaM datasets and maintain validation documentation
  • Able to generate regulatory submission-ready packages in an eCTD format
  • Ensure SAS programs adhere to SOPs, guidelines, and specifications
  • Provide feedback on protocols, CRFs, Statistical Analysis Plans
  • Provide input for the creation of database and analysis specifications
  • Produce reports, summaries and listings requested by manager
  • May interact with external vendors for validation of programs and datasets

 

  • Minimum of BS preferably in Health Sciences, Statistics, MIS, or Informatics, MS or above preferred
  • 6-10 years of SAS programming experience in pharma, CRO or related area (SAS certification preferred)
  • Proficient in all aspects of SAS (Base 9.4, Macros, Graph, SQL, Stat, ODS, templates)
  • Expert knowledge of CDISC terminology and architecture for both SDTM & ADaM
  • Relevant regulatory requirements and guidances (e.g., CFR 21 Part 11, FDA, ICH)
  • Ability to work independently with initiative and communicate well
  • Must be proficient working in a PC/Windows environment
  • Able to work on-site at company

 

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Job Id:

13442

Job Category:

Clinical & Life Sciences

Job Location:

Silver Spring, MD  2010

Security Clearance:

Not Defined

Business Unit:

Piper Companies