Talent.com
Biostatisticien principal FSP, RWE
Biostatisticien principal FSP, RWEIQVIA • Kirkland, Quebec, Canada
Biostatisticien principal FSP, RWE

Biostatisticien principal FSP, RWE

IQVIA • Kirkland, Quebec, Canada
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Level : FSP Principal Biostatistician for Pharmaceutical RWE

Location : Home-based in the Mexico

Why DSSS?

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while collaborating directly with expert cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary :

The Principal Biostatistician is responsible for providing statistical support for novel clinical research.

Additional Benefits :

  • Home-based remote working opportunities
  • Work / life balance as well as flexible schedules.
  • Collaborating with motivated, high-performance, statistical and research teams
  • Technical training and tailored development curriculum
  • Research opportunities that match your unique skillset
  • Promising career trajectory
  • Job stability : long-term engagements and re-deployment opportunities
  • Focus on bringing new therapies to market rather than project budgets and change orders.
  • Experience with regulatory submissions.
  • Engaging, fast-paced environment.
  • Good work-life balance.

Job Responsibilities :

Data Access and Collection :

  • Identify and access diverse RWD sources, such as electronic health records (EHRs), claims databases, patient registries, and other real-world data repositories.
  • Collaborate with data vendors and healthcare organizations to ensure data quality, compliance, and accessibility.
  • Develop robust data collection pipelines using advanced programming techniques to support study objectives.
  • Data Analysis and Statistical Modeling :

  • Design and execute statistical analyses of RWD to generate RWE for clinical, regulatory, and commercial purposes.
  • Apply advanced statistical methods, including propensity score matching, survival analysis, regression modeling, and machine learning, to derive meaningful insights.
  • Leverage strong programming skills to develop, validate, and optimize analytical models and scripts for complex RWD datasets.
  • Conduct comparative effectiveness research, health outcomes studies, and pharmacoeconomic analyses, addressing issues like confounding, bias, and missing data.
  • Study Design and Protocol Development :

  • Collaborate with cross-functional teams to design RWE studies, including retrospective cohort studies, case-control studies, and pragmatic trials.
  • Contribute to study protocols, statistical analysis plans (SAPs), and technical reports, ensuring programming components are clearly defined.
  • Ensure studies align with regulatory standards (e.g., FDA, EMA) for RWE submissions.
  • Reporting and Communication :

  • Prepare high-quality reports, manuscripts, and presentations summarizing RWE findings for internal stakeholders, regulatory authorities, and peer-reviewed publications.
  • Use programming skills to create automated reporting tools and dynamic data visualizations for non-technical audiences.
  • Provide strategic recommendations based on RWE to support drug development, market access, and lifecycle management.
  • Compliance and Quality Assurance :

  • Demonstrate strong understanding of and Ensure compliance with regulatory guidelines (e.g., FDA 21st Century Cures Act, EMA RWE framework) and industry standards (e.g., ISPOR, ISPE), as applicable to statistics.
  • Implement best practices for data integrity, reproducibility, and transparency through well-documented and efficient code.
  • Perform quality control and validation of statistical and programming outputs
  • Qualifications

  • PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
  • MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
  • Proven expertise in RWD / RWE studies, with hands-on experience analyzing EHRs, claims data, registries, or other real-world data sources.
  • Experience with different study designs, protocol development, and statistical analysis plan writing
  • Demonstrated track record of supporting regulatory submissions (e.g., FDA, EMA) using RWE.
  • Excellent problem-solving and critical-thinking skills.
  • Strong communication and collaboration abilities to work with cross-functional teams and external partners.
  • Ability to manage multiple projects and meet deadlines in a fast-paced environment.
  • Experience with statistical modelling of clinical data and statistical inference
  • Strong Programming Skills : Advanced proficiency in statistical programming languages such as R, Python, or SAS for data manipulation, statistical analysis, and automation.Experience with database querying (e.g., SQL) and managing large, complex datasets.Familiarity with data visualization tools (e.g., Tableau, Power BI, or R Shiny) to create impactful presentations of RWE findings.Knowledge of version control systems (e.g., Git) and reproducible research practices.
  • Proficiency in applying statistical methodologies for RWD, including propensity score methods, longitudinal data analysis, and causal inference techniques.
  • Based in a time zone within the United States or Europe (UTC-8 to UTC+2) to facilitate real-time collaboration
  • Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
  • Experience with CDISC, including SDTM, ADAM, CDASH.
  • Desired Experience :

  • No further specialized skills are applicable.
  • Note - -We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.

    #LI-Remote

    #LI-NITINMAHAJAN

    IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

    IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au

    Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

    IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

    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. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at :

    Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.

    Create a job alert for this search

    Principal • Kirkland, Quebec, Canada

    Similar jobs
    Clinical Trial Associate - REMOTE CANADA - saint-jérôme

    Clinical Trial Associate - REMOTE CANADA - saint-jérôme

    ICON Strategic Solutions • saint-jérôme, qc, ca
    Remote
    Full-time
    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 u...Show more
    Last updated: 7 days ago • Promoted
    Technicien(ne) en Toxicologie de développement et de la reproduction(DART)

    Technicien(ne) en Toxicologie de développement et de la reproduction(DART)

    ITR Laboratories Canada Inc. • Baie-D'Urfé, Québec, Canada
    Full-time +1
    Qui sommes-nous Chez les laboratoires ITR Canada Inc, notre mission est d'introduire de nouveaux médicaments sur les marchés mondiaux et d'améliorer la santé et le bien-être d'individus à travers...Show more
    Last updated: 30+ days ago • Promoted
    Dermatology Brand Leader - Primary Care

    Dermatology Brand Leader - Primary Care

    Organon Canada • Kirkland, Montreal (administrative region), Canada
    Full-time
    Une entreprise pharmaceutique recherche un(e) Chef(fe) de marque en dermatologie pour développer des stratégies d'engagement et établir des liens avec des professionnels de santé.Le candidat idéal ...Show more
    Last updated: 4 days ago • Promoted
    Senior Global Clinical Trial Manager - Oncology Hematology - Home Based - Canada - saint-jérôme

    Senior Global Clinical Trial Manager - Oncology Hematology - Home Based - Canada - saint-jérôme

    ICON Strategic Solutions • saint-jérôme, qc, ca
    Remote
    Full-time
    As a Senior Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Joining a well-established yet exp...Show more
    Last updated: 6 days ago • Promoted
    Clinical Project Manager - saint-jérôme

    Clinical Project Manager - saint-jérôme

    Upsilon Global • saint-jérôme, qc, ca
    Temporary
    Freelance CPM - Canada - Vaccines / Infectious Diseases.Upsilon Global are seeking an experienced Freelance Clinical Project Manager who's also happy to perform monitoring visits in a hybrid role for...Show more
    Last updated: 10 days ago • Promoted
    Senior Clinical Data Manager - saint-jérôme

    Senior Clinical Data Manager - saint-jérôme

    Warman O'Brien • saint-jérôme, qc, ca
    Full-time
    Join a Global Leader in Clinical Research.Are you a seasoned Clinical Data Manager with a passion for driving high-quality data outcomes across global clinical trials? We are looking for a Senior C...Show more
    Last updated: 30+ days ago • Promoted
    Analyste Microbiologie (exprience en salle strile)

    Analyste Microbiologie (exprience en salle strile)

    Neopharm • Blainville, QC, Canada
    Full-time
    Lutilisation du genre masculin a t adopte afin de faciliter la lecture et na aucune intention discriminatoire.NOUS SOMMES LA RECHERCHE D'UN ANALYSTE EN MICROBIOLOGIE (Exprience en salle strile)...Show more
    Last updated: 27 days ago • Promoted
    Technicien(ne) de laboratoire

    Technicien(ne) de laboratoire

    Groupe ABS • Blainville, QC, Canada
    Full-time
    Relevant du responsable de laboratoire, le titulaire du poste agira à titre de Technicien(ne) de laboratoire pour le Groupe ABS inc. Il devra principalement effectuer les essais de laboratoir...Show more
    Last updated: 30+ days ago • Promoted
    Study Director-DART, Toxicologist

    Study Director-DART, Toxicologist

    ITR Laboratories Canada Inc. • Baie-D'Urfé, Quebec, Canada
    Full-time +1
    Chez ITR Laboratoires Canada INC.Notre mission est d'apporter au monde de nouveaux médicaments qui soulagent les souffrances des patients atteints de maladies graves. Les Laboratoires ITR Canada est...Show more
    Last updated: 30+ days ago • Promoted
    Assistant(e) technique en pharmacie

    Assistant(e) technique en pharmacie

    Nora Solutions • Boisbriand, QC, Canada
    Permanent
    Assistant(e) technique en pharmacie.Notre client, une pharmacie communautaire d'une grande bannire, est la recherche d'un(e) assistant(e) technique en pharmacie (ATP), pour se joindre leur ...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Trial Manager - saint-jérôme

    Clinical Trial Manager - saint-jérôme

    Upsilon Global • saint-jérôme, qc, ca
    Temporary
    Freelance CTM / LCRA - Canada - Vaccines / Infectious Diseases.Upsilon Global are seeking an experienced Freelance Clinical Trial Manager / Lead CRA who's also happy to perform monitoring visits in a h...Show more
    Last updated: 10 days ago • Promoted
    Technicienne ou technicien de laboratoire médical diplômé(e)

    Technicienne ou technicien de laboratoire médical diplômé(e)

    Institut national de santé publique Qc (INSPQ) • Sainte-Anne-de-Bellevue, Québec, Canada
    Full-time
    Votre mandatPersonne qui effectue, à partir de spécimens, des analyses et des examens dans le domaine de la biologie médicale. Elle assure la validité technique des résultats à des fins diagnostique...Show more
    Last updated: 30+ days ago • Promoted
    Senior Statistical Programmer - saint-jérôme

    Senior Statistical Programmer - saint-jérôme

    Warman O'Brien • saint-jérôme, qc, ca
    Full-time
    Senior / Principal Statistical Programmer | Small CRO | Remote.We're partnered with a small CRO who are experiencing a large amount of growth within Biometrics. As a Senior Statistical Programmer, you...Show more
    Last updated: 30+ days ago • Promoted
    Électromécanicien - Mirabel - jusqu'à 32 $ l'heure + prime!

    Électromécanicien - Mirabel - jusqu'à 32 $ l'heure + prime!

    Services de Gestion Quantum Ltée • Blainville, Québec, Canada
    Permanent
    Poste : électromécanicien Lieu de travail : Mirabel Horaire de travail : lundi au vendredi 15 h 30 à minuit Voici une belle offre d'emploi pour les électromécaniciens qui aiment travailler sur le ...Show more
    Last updated: 30+ days ago • Promoted
    Mécanicien prévol

    Mécanicien prévol

    TAS Techno | Aero | Services • Mirabel, QC, Canada
    Full-time
    Préparer, vérifier et inspecter l'appareil pour les essais au sol et en vol.Effectuer le tests au sol et les tests en vol en assistant les pilotes. Réparation et à la modification de tous les problè...Show more
    Last updated: 30+ days ago • Promoted
    Directeur(rice) d'étude -DART, Toxicologue

    Directeur(rice) d'étude -DART, Toxicologue

    ITR Laboratories Canada Inc. • Baie-D'Urfé, Québec, Canada
    Full-time +1
    At ITR Laboratories Canada INC Our Mission is to bring new medicines to the world which relieve patients suffering from serious diseases. ITR Laboratories Canada has been servicing the pharmaceutic...Show more
    Last updated: 30+ days ago • Promoted
    Dentiste Associé — Autonomie Clinique & Mentorat

    Dentiste Associé — Autonomie Clinique & Mentorat

    123Dentist • Sainte-Marthe-sur-le-Lac
    Full-time
    Un réseau dentaire dynamique recherche un dentiste associé dans la région de Sainte-Marthe-sur-le-Lac.Le candidat devra pratiquer la dentisterie générale dans un environnement chaleureux et collabo...Show more
    Last updated: 15 days ago • Promoted
    Électromécanicien - licence C - jour de semaine - superbes avantages!

    Électromécanicien - licence C - jour de semaine - superbes avantages!

    Services de Gestion Quantum Ltée • Blainville, Québec, Canada
    Permanent
    Poste : électromécanicien - licence C Lieu de travail : Mirabel Horaire de travail : lundi au vendredi de 7 h à 15 h 20 Voici une belle offre d'emploi de jour pour un électromécanicien qui détient ...Show more
    Last updated: 30+ days ago • Promoted