Senior Biostatistics Programmer

Nutley, New Jersey
April 17, 2025
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Job Description

Job Requirements:

  • Expert in addressing technical challenges that connect SAS, CDISC and XML.
  • Excellent technical skills in SAS system and application development.
  • Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
  • Expert in integrating SAS with other leading technologies such as PDF, XML, Microsoft Office, to support electronic submissions.
  • Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle.
  • Annotate CRFs in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.
  • Review and quality assure CRF annotations produced by other programmers
  • Embrace and contribute to our culture of process improvements with a focus on streamlining our processes adding value to our business needs.
  • Review and quality assure data set and programming specifications produced by other programmers.
  • Accountable for development and maintenance of cross-functional / cross-department process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission.
  • Accountable for execution of process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission.
  • Engages appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM.
  • Accountable for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets, with high quality and on time.
  • Provides SDTM data production technology to CDO (Clinical Data Operations) related to SDTM data delivery and manages the activities of a team with a common focus.
  • Minimum 12 years of relevant programming and application development experience in CRO, Pharmaceutical or Biotech organizations.
  • Master’s Degree in Computer Science or Mathematics or any relevant field.

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