Principal Biostatistician Fsp, Rwe

Job Level : FSP Principal Biostatistician for Pharmaceutical RWELocation : Home-based in MexicoWhy 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 outputs.QualificationsPhD 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 applicableNote - -We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.

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