Biostatisticien principal FSP, RWE

Job Description -Job Level: FSP Principal Biostatistician for Pharmaceutical RWELocation: Home-based in CanadaWhy 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 opportunitiesWork/life balance as well as flexible schedules.Collaborating with motivated, high-performance, statistical and research teamsTechnical training and tailored development curriculumResearch opportunities that match your unique skillsetPromising career trajectoryJob stability: long-term engagements and re-deployment opportunitiesFocus 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 outputsQualificationsPhD 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 writingDemonstrated 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 inferenceStrong 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 collaborationUnderstanding 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-NITINMAHAJANIQVIA 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 , afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.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: , so that IQVIA can support your participation in the recruitment process.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.La fourchette salariale de base potentielle pour ce poste, annualisée, est de $116,300.00 - $235,400.00. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience; l’emplacement; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien-être et/ou d’autres bénéfices.The potential base pay range for this role, when annualized, is $116,300.00 - $235,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.