Principal Statistical Programmer

Title: Principal Statistical Programmer

Division / Function: Statistical Programming, Global Biometry

Overview

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

Responsibilities

• Ensure the efficiency and quality of biometry deliverables.
• Ensure all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs.
• Lead statistical programming activities, including analyzing, integrating, and reporting clinical trial data to produce quality and timely deliverables.
• Perform data analysis using SAS for the summary and interpretation of clinical trial data.
• 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 and QC CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submissions.
• Complete full QC validation of in‑house created graphs, tables, and figures, interacting with statisticians, programmers, and other clinical team members.
• 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 influencing statistical programming and data management.
• Work with CRO statisticians and programmers, reviewing and QCing their work and deliverables.
• Understand clinical trial design and reporting processes, including regulatory reporting requirements and CDISC implementation.
• Execute and manage multiple simultaneous projects and deadlines in a fast‑paced environment with shifting priorities and resources.

Education & Certifications

Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or another related scientific discipline.

Experience

5+ years of experience in statistical programming or a related occupation.

Languages

English.

Key Technical Competencies

• Demonstrable knowledge of SAS programming language.
• Demonstrable knowledge of regulatory requirements (FDA, ICH).
• Demonstrable experience in organizing NDA/IND regulatory submissions.
• Demonstrable experience extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures.
• Demonstrable experience with SAS/MACRO, SQL and SAS/BASE procedures.
• Demonstrable experience with SAS/GRAPH and statistical procedures.
• Demonstrable experience with clinical data and medical dictionaries.
• Demonstrable understanding of clinical trials and how programming deliverables fit into the process.
• Demonstrable knowledge of data structures (tall and wide).
• Demonstrable experience developing and QCing SDTM, ADaM, Define XML, and Reviewer’s Guide as per CDISC specifications.
• Demonstrable ability to draft programming requirements from SAP.
• Demonstrable experience with study reporting.
• Demonstrable ability to propose and implement solutions to technical coding issues.

Equal Opportunity Statement

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons «The Real Us» et où la diversité des perspectives et des expériences est valorisée. Tous les candidats seront traités de façon équitable, sans discrimination.