IQVIA
Overview
Job Level:
FSP Principal Biostatistician for RWE Research Location:
Home-based in the U.S. or Canada Data Sciences Staffing Solutions (DSSS) is a unit within IQVIA that provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This enables you to enjoy the benefits of working for a global CRO while collaborating with sponsor teams. Sponsor clients include world-class pharmaceutical and biotech companies offering opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician provides the full range of statistical support for drug development based on real world evidence (RWE). Benefits: Home-based remote working opportunities Work/life balance and flexible schedules Collaborating with motivated, high-performance statistical and research teams Technical training and tailored development curriculum Research opportunities aligned with your skillset Promising career trajectory Job stability: long-term engagements and redeployment opportunities Focus on bringing new therapies to market Experience with regulatory submissions Engaging, fast-paced environment Good work-life balance
Responsibilities
Collaborate with multi-disciplinary project teams to establish project goals and timelines. Serve as statistical lead and represent Biometrics on health outcomes and epidemiology studies. Serve as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting. Write statistical analysis plans. Provide strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians. Leverage administrative claims, EMR, registries, or other real-world data and recommend optimal analyses. Select and implement appropriate analytical methods, including statistical models or ML models, to align with business objectives. Develop high-quality study protocols, SAPs, study reports, and other study documents. Identify innovation opportunities for the use of real-world data (RWD). Establish effective communication with internal stakeholders to support RWD strategy and usage. Maintain high standards of data accuracy and integrity with rigorous quality control throughout data handling and analysis. Demonstrate ability to adapt to new requirements and handle ad-hoc requests efficiently.
Qualifications
In-depth knowledge of RWE databases (large administrative claims data, EMR, disease registries, and clinical trial data). Experience evaluating and developing RWE from conceptualization to application. Familiarity with LOINC codes, reimbursement and lab data interpretation; ability to implement surrogate variable algorithms (phenotype definitions, proxies for clinical endpoints). Ability to execute statistical analysis plans using advanced programming techniques for complex analyses of real-world data. Ability to interpret and communicate research results to internal and external audiences. Understanding of ICH GCP and E9 and general industry practices. Knowledge of global regulatory and HTA requirements for RWE.
Education and Experience
PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience. Experience leading secondary data analysis (medical claims, EMR, chart reviews, registries). Hands-on experience as a Project Statistician with real-world data (EMR/EHR and claims datasets) for examples such as Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.; ability to prepare LOA, mock TFLs, protocol and SAPs. Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD. Excellent organizational skills and ability to lead multiple projects to completion. SME-level proficiency in SAS programming for complex inclusion/exclusion criteria, propensity score matching, and outcome metrics; expertise in R is valued. Experience with CDISC ADAM datasets. Extensive collaboration with stakeholders such as medical affairs and health economics.
Preferred but not Required Experience
Understanding of payer landscape, health economic outcomes, and value demonstration frameworks. Exposure to regulatory submissions and HTA support.
#LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. Learn more at https://jobs.iqvia.com 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, status as a protected veteran, or any other status protected by applicable law. Learn more at https://jobs.iqvia.com/eoe
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Job Level:
FSP Principal Biostatistician for RWE Research Location:
Home-based in the U.S. or Canada Data Sciences Staffing Solutions (DSSS) is a unit within IQVIA that provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This enables you to enjoy the benefits of working for a global CRO while collaborating with sponsor teams. Sponsor clients include world-class pharmaceutical and biotech companies offering opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician provides the full range of statistical support for drug development based on real world evidence (RWE). Benefits: Home-based remote working opportunities Work/life balance and flexible schedules Collaborating with motivated, high-performance statistical and research teams Technical training and tailored development curriculum Research opportunities aligned with your skillset Promising career trajectory Job stability: long-term engagements and redeployment opportunities Focus on bringing new therapies to market Experience with regulatory submissions Engaging, fast-paced environment Good work-life balance
Responsibilities
Collaborate with multi-disciplinary project teams to establish project goals and timelines. Serve as statistical lead and represent Biometrics on health outcomes and epidemiology studies. Serve as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting. Write statistical analysis plans. Provide strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians. Leverage administrative claims, EMR, registries, or other real-world data and recommend optimal analyses. Select and implement appropriate analytical methods, including statistical models or ML models, to align with business objectives. Develop high-quality study protocols, SAPs, study reports, and other study documents. Identify innovation opportunities for the use of real-world data (RWD). Establish effective communication with internal stakeholders to support RWD strategy and usage. Maintain high standards of data accuracy and integrity with rigorous quality control throughout data handling and analysis. Demonstrate ability to adapt to new requirements and handle ad-hoc requests efficiently.
Qualifications
In-depth knowledge of RWE databases (large administrative claims data, EMR, disease registries, and clinical trial data). Experience evaluating and developing RWE from conceptualization to application. Familiarity with LOINC codes, reimbursement and lab data interpretation; ability to implement surrogate variable algorithms (phenotype definitions, proxies for clinical endpoints). Ability to execute statistical analysis plans using advanced programming techniques for complex analyses of real-world data. Ability to interpret and communicate research results to internal and external audiences. Understanding of ICH GCP and E9 and general industry practices. Knowledge of global regulatory and HTA requirements for RWE.
Education and Experience
PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience. Experience leading secondary data analysis (medical claims, EMR, chart reviews, registries). Hands-on experience as a Project Statistician with real-world data (EMR/EHR and claims datasets) for examples such as Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.; ability to prepare LOA, mock TFLs, protocol and SAPs. Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD. Excellent organizational skills and ability to lead multiple projects to completion. SME-level proficiency in SAS programming for complex inclusion/exclusion criteria, propensity score matching, and outcome metrics; expertise in R is valued. Experience with CDISC ADAM datasets. Extensive collaboration with stakeholders such as medical affairs and health economics.
Preferred but not Required Experience
Understanding of payer landscape, health economic outcomes, and value demonstration frameworks. Exposure to regulatory submissions and HTA support.
#LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. Learn more at https://jobs.iqvia.com 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, status as a protected veteran, or any other status protected by applicable law. Learn more at https://jobs.iqvia.com/eoe
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