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.

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; and,

• Demonstrable ability proposing and implementing solutions to technical coding issues

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même