88BIOSCIENCE is a new Lifescience recruitment brand from 88JOBS, the multi-specialist recruitment platform based in Europe and Asia. Our mission is to provide a professional, friendly and overall, reliable service for those looking for work and companies looking for staff.
Today, 88BIOSCIENCE is looking for a SAS PROGRAMMING DIRECTOR.
The hiring company:
Our client is a pharmaceutical company specialized in building major clinical development programs (oncology, neurodegenerative diseases…).
The job responsibilities:
You will have to:
* Ensure the integrity of programming and computing solutions for a global clinical drug development program.
* Ensure the successful and timely delivery of the Investigator's Brochure (IB) and Development Safety Update Report (DSUR) every year.
* Lead or support electronic submission preparation and review processes.
* Oversee the complete execution of final production output, ensuring the delivery of high-quality and timely programming deliverables for Clinical Study Reports (CSRs) and regulatory submissions.
* Collaborate with statisticians to develop project-level programming standards and ensure compliance with project-level, disease-area, and company standards. Provide support for the development of disease-area programming standards when necessary.
* Ensure consistency and compliance with company standards in documents and specifications, including electronic Case Report Forms (eCRFs) and data structures, tables, listings, and figures for Phase I-III clinical trials and submission activities within the responsible drug project.
* Program analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-III clinical trials and regulatory submissions according to established specifications.
* Prepare Case Report Tabulations as required for submission.
* Collaborate with statisticians to develop and update project-level programming specifications for analysis datasets and pooled datasets (e.g., in Statistical Analysis Plans and Table, Listing, and Figure shells) for the clinical drug project.
* Develop advanced MACROs for general use by programmers.
* Maintain up-to-date advanced knowledge of programming software, such as SAS, R, and Splus.
* Ensure quality control compliance and take responsibility for project records, including archiving of programming and associated documentation. Maintain audit readiness for quality programming deliverables for the drug project.
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