- Independently develop accurate and CDISC compliant ADaM specifications.
- Independently develop/validate programs that generate analysis datasets based on ADaM specifications.
- Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP).
- Good understanding of regulatory requirements. Prepare XPTs , Reviewer's Guide and analysis metadata report, executable programs for CRT packages.
- Run P21 checks and resolve the P21 validation report related error and document details.
- Perform quality control on final reports. Generate the adhoc and custom reports as requested.
- Provide QC and validation reports and document corresponding details.
- Communicate with programming and statistics leads, data managers and other team members.
- Provide project progress updates of programming activities.
- BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences - 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
- Required Skills Include: - Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat - Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus -
- Experience with all clinical phases I, II, III and IV of trails is desirable
- Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
- Strong problem-solving skills
- Good organizational and time management skills.
- Excellent communication and interpersonal skills and capability of communicating technical concepts
- Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
- Should have experience in lead role.
- Experience in submission to regulatory authorities
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
- États-Unis
- Canada
- Europe
- Royaume-Uni
- Créer, valider, exécuter et générer des programmes statistiques pour la production de listes, de résultats d'innocuité et d'efficacité (ensembles de données d'analyse, tableaux, figures).
- Créer, examiner et finaliser les spécifications de l'ensemble des données d'analyse.
- Créer, utiliser et modifier des macros au niveau du projet ou du service.
- Diriger une ou plusieurs équipes pour produire des résultats de programmation SAS de qualité supérieure pour tous les produits livrables.
- Assurer le mentorat et contribuer à la formation du personnel subalterne.
- Contrôler la qualité et la productivité globales des membres de l'équipe de programmation assignée.
- Fournir la programmation des analyses (ADaM/TLF), le développement et le soutien des spécifications ADaM pour votre équipe ou en collaboration avec elle.
- Assurer l'achèvement de toute la documentation du projet de programmation.
- Être responsable du développement, de la tenue à jour et de la validation de la structure de données et des logiciels standard.
- Diriger et exécuter les livrables en matière de programmation pour au moins une étude à la fois à l'échelle mondiale (en tant que responsable de la programmation mondiale) et s'assurer que les priorités en matière de concurrence sont gérées de manière appropriée.
- Agir à titre de conseiller(-ère) technique pour tous les problèmes techniques au sein de l'équipe qui lui est affectée.
- Travailler en tant qu'expert(e) pour au moins un domaine et agir en tant que personne-ressource pour l'équipe ou le service pour toute question relative à ces domaines.
- Diriger et superviser des initiatives techniques visant à améliorer les capacités techniques de l'équipe/du service de programmation.
- Diriger et superviser des initiatives techniques visant à améliorer les fonctionnalités du service/à mettre en œuvre de nouvelles technologies.
- Offrir des services avec une grande capacité d'interaction directe avec la clientèle, notamment pouvoir anticiper les besoins des clients et mettre en œuvre des solutions novatrices.
- Établir et favoriser des relations avec les clients grâce à une gestion de projet et à une communication efficaces.
- Ses tâches consistent notamment à : diriger et gérer les produits livrables de l'équipe de programmation assignée au niveau de l'étude et du programme pour s'assurer que les objectifs du projet sont atteints dans les limites du budget, dans les délais convenus et dans le respect des normes de qualité les plus élevées.
- Organiser et mettre en œuvre de façon proactive une planification efficace des ressources, une répartition des tâches et assurer le suivi de la charge de travail conformément aux mesures convenues (p. ex., IRC) et aux normes de qualité.
- Fournir des livrables de programmation statistique de grande qualité pour toutes les affectations qui respectent de façon uniforme les échéanciers de l'étude, les normes de qualité, les exigences de parrainage et/ou les exigences contractuelles.
- Faire preuve d'une utilisation efficace de SAS et respecter les directives de programmation SAS.
- Créer et valider les résultats en matière de listes et de résultats d'innocuité (ensembles de données d'analyse, tableaux, figures).
- Créer et valider les résultats en matière d'efficacité (ensembles de données d'analyse, tableaux, figures).
- Créer et valider des programmes complexes (tels que des macros de projet ou de service).
- Créer des spécifications d'ensembles de données d'analyse (ADaM ou spécifiques au client).
- Configurer des répertoires de programmation standard et des utilitaires de démarrage.
- Créer, documenter et valider les macros de projet/étude en matière de tableaux, de listes et de figures.
- Assurer une liaison efficace avec les autres fonctions d'ICON (p. ex., PM, DM, MW), selon les besoins, pendant la durée du projet.
- 4 à 8 ans d'expérience dans un poste de programmeur(-euse) statistique, dans le secteur de la recherche clinique;
- Une expérience en matière de direction d'études de phase II et/ou de phase III;
- Une expérience dans la création et la validation d'ensembles de données d'analyse (norme Admin CDISC de préférence), et de tableaux, de listes et de figures (TLF);
- Une solide expérience en matière de programmation SAS;
- Une expérience en Pinnacle 21 serait un atout considérable;
- Des compétences en matière d'encadrement professionnel jumelées à des compétences de communication exceptionnelles;
- Un diplôme de baccalauréat (en statistique, mathématiques, informatique ou dans une discipline scientifique connexe); un diplôme de maîtrise ou de Ph.D. de préférence.
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Principal Statistical Programmer-US or Canada Remote - ICON Strategic Solutions
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Description
ICON 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 development.
What you will be doing: