Principal Statistical Programmer

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

• 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.

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.
• Demonstrable ability proposing and implementing solutions to technical coding issues.