Principal Biostatistician FSP, RWE

Required Knowledge, Skills, and Abilities:

• In-depth knowledge of RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data.
• Demonstrated ability in evaluation and development of RWE from conceptualization through application.
• Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints)
• Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to real-world evidence.
• Ability to effectively interpret and communicate research results to internal and external audiences.
• Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard
• Knowledge of global regulatory and HTA requirements for RWE
• Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
• SME-level proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria, conduct propensity score matching, and develop outcome metrics.

Required Education and Experience: (Minimal acceptable level of education, work experience, and competency)

• Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
• Solid hands-on experience as Project statistician with real-world data, including EMR/EHR and claims datasets (e.g., Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.)
• Fluency in LOA, mock TFLs, protocol and SAP
• Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD
• Experience with CDISC ADAM datasets.
• Extensive working experience 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, HTA support.
• Expertise in R is also valued.

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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 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. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $111,000.00 - $309,000.00. 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 welfare and/or other benefits.