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Manager statistical programming

Granada
Indefinido
SEC Life Sciences
Publicada el 12 mayo
Descripción

We are partnered with a boundary-pushing organisation dedicated to improving lives through innovative healthcare solutions. With over 100 years of heritage in the pharmaceutical sector, their mission is to deliver new standards of care that enhance the quality of life globally.

The firm focuses on two core areas :

* Cardiovascular Health : Protecting people from cardiovascular disease, the leading cause of death in Europe.
* Oncology : Striving to become a global pharma innovator by creating novel therapies for cancer patients.

This position offers the flexibility to work from several countries across Europe or in Canada. This is a 2-year fixed term position.

Your Role as Manager Statistical Programming

* Oversee the end-to-end delivery of statistical programming services for assigned studies.
* Develop and validate SAS programmes to create SDTM and ADaM datasets and TFLs.
* Collaborate with CROs and other vendors to ensure high-quality deliverables are on time and within budget.
* Review Statistical Analysis Plans (SAPs) and Table, Figure, and Listing (TFL) shells from a programming perspective.
* Ensure timely and accurate completion of statistical programming deliverables.
* Manage routine oversight of vendor delivery to ensure compliance with protocols, standards, and regulatory guidelines.
* Participate in global initiatives to improve process and efficiency.
* Maintain inspection readiness and prepare for potential audits linked to assigned studies.

Experience and Qualifications for the Manager Statistical Programming Role

* Bachelor's degree in Statistics, Computer Science, Mathematics, or a related field.
* Relevant experience in statistical programming within the pharmaceutical industry.
* Proficiency in SAS programming.
* Working knowledge of SDTM and ADaM datasets, TFLs, and related industry standards.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal skills.
* Ability to manage multiple projects and collaborate with various stakeholders.
* Understanding of regulatory requirements and guidelines for statistical programming.
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