Biostatisticien Senior FSP, Phase Tardive

FSP Senior Biostatistician for Phase 2/3 / Biostatisticien senior FSP pour la phase 2/3 Location: Home-based in Canada / Lieu: À domicile au Canada Why DSSS? Data Sciences Staffing Solutions, DS3, is a unit within IQVIA that provides full embedded resources through a Functional Service Provider (FSP) partnership. That means you get all the benefits of working for an industry‑leading global CRO while collaborating with sponsor teams and using sponsor systems. These sponsors include world‑class pharmaceutical and biotech companies, giving you unique opportunities to influence the future of medicine and advance therapies to market. Pourquoi DSSS ? Data Sciences Staffing Solutions, DS3, est une unité au sein d’IQVIA qui fournit des ressources entièrement intégrées grâce à un partenariat de fournisseur de services fonctionnels (FSP). Vous bénéficiez ainsi de tous les avantages de travailler pour un CRO mondial de premier plan tout en collaborant avec les équipes des sponsors et en utilisant leurs systèmes. Job Summary / Résumé du poste The Senior Biostatistician is responsible for providing statistical support for drug development programs in phases 2 or 3 with efficacy and safety endpoints. Le biostatisticien senior est chargé de fournir un soutien statistique aux programmes de développement de médicaments en phase 2 ou 3 avec des critères d’efficacité et de sécurité. Additional Benefits / Avantages supplémentaires Home‑based remote working opportunities / Possibilités de travail à distance à domicile Work/life balance and flexible schedules / Équilibre travail/vie personnelle et horaires flexibles Collaboration with motivated, high‑performance teams / Collaboration avec des équipes de recherche et de statistique motivées et performantes Technical training and tailored development curriculum / Formation technique et programme de développement personnalisé Research opportunities that match your unique skillset / Opportunités de recherche correspondantes à vos compétences uniques Promising career trajectory / Trajectoire de carrière prometteuse Job stability: long‑term engagements and re‑deployment opportunities / Stabilité de l’emploi : engagements à long terme et opportunités de redéploiement Focus on bringing new therapies to market instead of project budgets and change orders / Se concentrer sur la mise sur le marché de nouvelles thérapies plutôt que sur les budgets de projet et les ordres de modification Experience with regulatory submissions / Expérience des soumissions réglementaires Engaging, fast‑paced environment / Environnement engageant et rapide Good work‑life balance / Bon équilibre entre vie professionnelle et vie privée Job Responsibilities / Responsabilités du poste Collaborate with multidisciplinary project teams to establish project timelines. Provide statistical input to study synopses and protocols. Write or review the statistical sections of clinical trial protocols, consulting with internal and external experts. Write or review statistical analysis plans, dataset and TLF specifications. Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming of tables, listings, and figures. Mateilger with Data Management, Statistical Programming, and Clinical Development, bringing statistical expertise. Use SAS and/or R to perform inferential analyses and validate important data derivations and TFL. Support exploratory analyses and publications. Contribute to clinical study reports and other regulatory documents (e.g., DSURs, Briefing Documents, Benefit‑Risk analyses, IB). Participate in NDA and related activities. Attend meetings to support Biostatistics and the Development Team. Demonstrate ability to work independently, manage projects, and make decisions. Effectively communicate statistical concepts. Ensure compliance with SOPs and best practices for quality work products. Qualifications / Qualifications (niveau minimal acceptable) PhD in Statistics, Biostatistics, or a related field with 3+ years of industry experience. MS in Statistics, Biostatistics, or a related field with 5+ years of industry experience. Understanding of ICH and FDA Guidance and general knowledge of industry practices and standards. Experience with CDISC, including SDTM, ADaM, and CDASH. Desired Experience / Expérience souhaitée Knowledge of simulations, multivariate analyses, and biomarker analyses. Experience in a range of therapeutic areas. Production programming of statistical outputs. Regulatory submission activities. Estimand framework. Equal Opportunity Statement IQVIA is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. #J-18808-Ljbffr