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À±½·ÊÓƵ is seeking a Statistical Programmer - Submissions for a Senior position. This role involves supporting regulatory submissions, producing and validating datasets, and ensuring high-quality outputs within set timelines. The position offers flexibility in work location and requires occasional travel for events.

Responsibilities:

• Program datasets including complex efficacy and lab data.
• Serve as an independent technical expert and program complex non-efficacy outputs.
• Conduct senior reviews and quality control of non-statistical outputs.
• Develop and implement standard macros and perform user acceptance testing.
• Create, QC, and update complex dataset specifications for various studies.
• Provide consultancy and training on SDTM, ADaM, and CRT standards.
• Stay informed on regulatory guidelines and implement PHASTAR CRT tools.
• Lead programming projects, ensuring quality and timely delivery.
• Collaborate with statisticians and project managers on resources and deliverables.
• Act as a point of contact for programming issues and ensure cohesive team operations.
• Develop and deliver company-wide training and update processes and SOPs.

Key Skills and Requirements:

• Degree in Computer Science or another relevant field.
• Experience in SAS programming within the pharmaceutical industry.
• Understanding of clinical trial design and regulatory submissions.
• Familiarity with GCP and regulatory requirements.
• Knowledge of SDTM and ADaM CDISC standards.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.