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System One Services Statistical Programmer III in Gaithersburg, Maryland

Statistical Programmer IIIGaithersburg, MD

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:186789

Date Posted:02/23/2021

Permanent Statistical Programmer III Opportunity.

Responsibilities include but are not limited to:

  • Generate SDTM/ADAM datasets and associated specs files; perform validation to SDTM/ADAM datasets that generated by other programmers per specs files

  • Generate TFLs per table shells or adhoc requests; perform validation to TFLs that generated by other programmers per table shells or adhoc requests

  • Provide programming support per requests from Biostatisticians or other functional areas such as Clinical Operations or Medical Writing

  • Attend internal or cross-functional meetings with inputs from Statistical Programming group

  • Provide progress updates of ongoing tasks to line manager

Minimum Requirements:

  • BS degree in Statistics, Computer Science, or related field.

  • Five to seven years SAS programming experiences (Base SAS, SAS/STAT, and SAS macro language) on phase I, II, or III clinical trial data, in creating/validating SAS datasets and TFLs (per SAP/table shell/specs) for CSR in pharmaceutical, biotech, or CRO companies.

  • Programming experience in producing outputs for periodical safety report (such as SRT, DSMB, DSUR, or ClinicalTrials.gov), or outputs to support publications.

  • Experience creating CDISC SDTM/ADAM domains, as well as associated specs, from phase I/II/III clinical trial data.

  • Experience using the SAS Output Delivery System to output figures, tables and listings.

  • Good verbal and written communication skills, detail orientated, able to work comfortably with tight deadlines.

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