Principal Statistical Programmer

Ipsen • Paris, TX

60d • Hybrid

About The Position

Position will participate in production/QC programming, project coordination, CRO management and oversight of vendor programming across Ipsen rare disease studies

Requirements

• Position requires a Bachelor's degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or other related Scientific Discipline.
• 5+ years of experience in the job offered or in a related occupation
• English
• 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;
• Demonstrable ability proposing and implementing solutions to technical coding issues

Responsibilities

• To 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Industry: Chemical Manufacturing
• Number of Employees: 1,001-5,000 employees