drjobs Statistical Programmer

Statistical Programmer

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1 Vacancy
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Job Location drjobs

Charlotte - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:

  • Create specifications for the structure of ADaM data sets for individual studies.
  • Develop SAS programs for creation & validation of ADaM data sets following CDISC standards & of Tables Listings & Figures.
  • Ensure accuracy of SAS programs by reviewing code log & output files.
  • Review output to ensure consistency with output for other activities (CSR ISS ISE).
  • Create documentation for regulatory filings including reviewers guides & data definition documents.
  • Participate in development of SAS Macros.

Requirements:

  • Must possess a BS or foreign academic equivalent in Statistics Biostatistics Computer Science or a related field.
  • Must have 6 years of experience in pharmaceutical industry.
  • developing reviewing & executing code using SAS Enterprise Guide &/or SAS Studio.
  • performing programming tasks including data processing & manipulation using SAS BASE data analysis using SAS STAT & data reporting using SAS ODS.
  • using SAS macro variables & macro functions including debugging the macro.
  • developing & validating programming code for derivation of key variables in Trial Design SDTM domains.
  • developing & validating ADaM datasets in compliance with CDISC standards & developing Tables Listings & Figures.
  • developing & validating programming code using SAS procedures to implement statistical methodologies for analysis of categorical & continuous variables including linear regression categorical data analysis survival analysis & significance testing.
  • creating or reviewing documentation for regulatory filings including reviewers guides & data definition documents.
  • complying with FDA EMA & other regulatory agencies/ICH guidelines & relevant regulatory requirements.

Employment Type

Full Time

Company Industry

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