Job Duties:
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
Qualifications and Education required:
Master’s Degree in Computer Science or Mathematics or any relevant field.
Minimum 12 years of relevant programming and application development experience in CRO, Pharmaceutical or Biotech organizations.
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