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SAS Programmer Biostatistics
* Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting.
* Review the programming specifications and table mockups in the Statistical Analysis Plan for completeness, correctness and adherence to sited department guidelines and SOPs. Ensure all programming issues are resolved and updated in the SAP. Ensure additional specifications are properly documented once programming commences.
* Transform specifications in the Statistical Analysis Plan into fully documented, validated programs supporting both safety and efficacy displays and analysis data sets required for the Clinical Study Report.
* Provide fully documented, validated programs in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), internal Safety Review Teams, etc.
* Provide programming support for electronic submissions to regulatory agencies worldwide, including creation of CDISC-compliant databases.
* Responsible for vendor management of the statistical programming function, including TLF quality/standards and adherence to guidelines and SOPs.
* Bachelors or Masterís degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific discipline.
* Minimum 5 years work experience in a programming role preferably supporting clinical trials.
* Advanced knowledge of / experience with SAS and other relevant programming software.
* Experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills.
* Experience in FDA/EMA trial submissions.
* Experience in leading programmer support for multiple clinical trials and submission activities.
* Good understanding of global clinical trial / project practices, procedures, methodologies.
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