Ipsen
Title:
Principal Statistical Programmer
Company:
Ipsen Innovation (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
Position
Job Title: Principal Statistical Programmer
Division / Function: Statistical Programming, Global Biometry
Summary / purpose of the position
Position will participate in production/QC programming, project coordination, CRO management and oversight of vendor programming across Ipsen rare disease studies
Main responsibilities / job expectations
Knowledge, abilities & experience
Education / Certifications:
Position requires a Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or other related Scientific Discipline.
Experience:
5+ years of experience in the job offered or in a related occupation
Languages:
English
Key Technical Competencies Required
• Demonstrable knowledge of SAS programming language;
• Demonstrable knowledge of regulatory requirements (FDA, ICH);
• Demonstrable experience in organizing NDA/s NDA regulatory submissions;
• Demonstrable experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures;
• Demonstrable experience of SAS/MACRO, SQL and SAS/BASE procedures;
• Demonstrable experience of SAS/GRAPH and Statistical procedures;
• Demonstrable experience of Clinical data and medical dictionaries;
• Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected;
• Demonstrable data structure understanding (tall and wide structures);
• Demonstrable experience in developing and QC of SDTM, ADaM, Define XML and Reviewer’s Guide as per the CDISC specifications;
• Demonstrable ability to draft programming requirements from SAP;
• Demonstrable experience with study reporting; and,
• Demonstrable ability proposing and implementing solutions to technical coding issues
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