Data Analyst
Genesys
AWSAzureCloudGoogle Cloud PlatformPythonSQLTableau
Principal Biostatistician, FSP, RWE
IQVIA
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇲🇽 Mexico
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud PlatformPythonSQLTableau
About the role
- 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
- 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
- Develop, validate, and optimize analytical models and scripts for complex RWD datasets using strong programming skills
- Conduct comparative effectiveness research, health outcomes studies, and pharmacoeconomic analyses addressing confounding, bias, and missing data
- Collaborate with cross-functional teams to design RWE studies, contribute to study protocols, statistical analysis plans (SAPs), and technical reports
- Ensure studies align with regulatory standards (e.g., FDA, EMA) for RWE submissions
- Prepare high-quality reports, manuscripts, and presentations summarizing RWE findings for internal stakeholders, regulatory authorities, and peer-reviewed publications
- 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
- Ensure compliance with regulatory guidelines (e.g., FDA 21st Century Cures Act, EMA RWE framework) and industry standards (e.g., ISPOR, ISPE)
- 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
Requirements
- 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
- 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)
- 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
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
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysispropensity score matchingsurvival analysisregression modelingmachine learningstatistical programming (R, Python, SAS)database querying (SQL)data manipulationanalytical model developmentdata collection pipeline development
Soft skills
problem-solvingcritical thinkingcommunicationcollaborationproject managementtime managementadaptabilityattention to detailstrategic thinkinginterpersonal skills
Certifications
PhD in StatisticsPhD in BiostatisticsMS in StatisticsMS in Biostatistics
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