Principal Biostatistician Fsp, Rwe

**Job Level**:FSP Principal Biostatistician for Pharmaceutical RWE**Location**:Home-based in 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.**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.- 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.- Based in a time zone within the United States or Europe