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 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. 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 Show less
