Ipsen
Principal Statistical Programmer
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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
- Ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs;
- Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data;
- Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE); create/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources;
- Complete full QC validation of in-house created graphs/tables/figures and interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements;
- Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management;
- Work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and, execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
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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
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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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