General Description:
Provide project support for RWD/RWE analyses.
Essential Functions of the job:
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Design, plan and lead statistical analyses for Real-World Data (RWD) and Real-World Evidence (RWE) studies, including comparative effectiveness, safety, observational studies, external control arms, and outcomes research.
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Oversee and validate statistical programming deliverables to ensure analyses are accurate, reproducible and aligned with study objectives, regulatory and publication standards.
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Perform statistical programming using relevant programming languages in big data environment to support data extraction, analysis, validation and generation of study results.
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Apply AI capabilities to enhance data preparation, code development, analytical efficiency and workflow automation.
Responsibilities:
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Develops individual protocol/SAP and determines appropriate statistical methodology for RWD/RWE studies.
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Analyzes large datasets from diverse sources, including claims databases, EHR, registries, and patient-reported outcomes.
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Participates in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.
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Collaborates with the statistical programming staff to ensure that all programs meet analysis and external requirements.
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Performs key and innovative part of the analyses and interprets results.
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Prepares oral and written reports to effectively communicate results.
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Reviews stat related documents during projects initiation, conduct and reporting when external vendors involved.
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Is involved in research activities for innovative statistical methods and applications.
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Prepares materials and conducts training to internal/external audience in venue initiated by MA and commercial.
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Provides statistical consultation and review to other request from other functions (i.e. clinical development or commercial).
Computer Skills: R, Python, SAS, SQL, Microsoft office apps.
Other Qualifications:
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Senior Manager, Biostatistics: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 2 years relevant work experience, or a Master's degree with a minimum of 4 years relevant work experience.
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Advanced proficiency in relational databases and programming languages such as R, Python, SAS, or SQL in big data environment.
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Advanced knowledge in Real-World Data (RWD), HEOR, and Epidemiologic methodology, including study design, statistical analysis and interpretation.
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Demonstrates interest in statistical research activities and application of novel methods to clinical trial development and RWE.
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Basic good presentation, oral and written communication skills.
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Ability to learn, being proactive, motivated, and consistently focus on details and execution.
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Ability to work in a team environment with cross-functional team members.
Travel: Yes, depends on needs.
Education Required:
Senior Manager, Biostatistics: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 2 years relevant work experience, or a Master's degree with a minimum of 4 years relevant work experience.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.