Principal Statistical Programmer

il y a 1 semaine

Paris, Île-de-France Ipsen Temps plein

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 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

  • Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France Excelya Temps plein

    About the RoleExcelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.As a Statistical Programmer,...

  • Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France Excelya Temps plein

    About the RoleExcelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.As a Statistical Programmer,...

  • Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France Excelya Temps plein

    About the RoleExcelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.As a Statistical Programmer,...

  • Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France Excelya Temps plein

    About the RoleExcelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.As a Statistical Programmer,...

  • Senior Statistical Programmer I

    il y a 1 semaine

    Paris, Île-de-France ICON plc Temps plein

    Senior Statistical Programmer - IndiaICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Statistical Programmer I to...

  • Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France Excelya Temps plein

    About the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in...

  • Senior Statistical Programmer

    il y a 1 semaine

    Paris, Île-de-France IQVIA Temps plein

    Why IQVIAThis role will be dedicated to one of IQVIA's largest clients through a Functional Service Provider (FSP) type partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech...

  • Senior Statistical Programmer

    il y a 11 heures

    Paris, Île-de-France IQVIA Temps plein

    Why IQVIAThis role will be dedicated to one of IQVIA's largest clients through a Functional Service Provider (FSP) type partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech...

  • Directeur programmes/Directrice programmes

    il y a 4 jours

    Paris, Île-de-France DCS EASYWARE Temps plein

    Nous recherchons unDirecteur de programmepour intervenir dans le cadre du Programme Galaxie.L'organisation lance la mise en place de la CMS du futur (Configuration Management Database), destinée à moderniser et structurer l'ensemble de la gestion des configurations du système d'information.Ce programme repose sur trois briques principales :des CMDB de...

  • Direction de Programme

    il y a 1 semaine

    Paris, Île-de-France Free-Work Temps plein

    Espace freelance recherche pour l'un de ses clients un : Directeur de Programme (H/F)Vos principales missions :Gestion de la planification : Élaborer et maintenir le calendrier global, garantir le respect des délais et l'optimisation des ressources.Coordination des projets : Superviser les 7 chantiers du programme et assurer leur alignement avec les...