Job Details

General Description:

Provide project support for RWD/RWE analyses.

Essential Functions of the job:

• 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.

• Oversee and validate statistical programming deliverables to ensure analyses are accurate, reproducible and aligned with study objectives, regulatory and publication standards.

• Perform statistical programming using relevant programming languages in big data environment to support data extraction, analysis, validation and generation of study results.

• Apply AI capabilities to enhance data preparation, code development, analytical efficiency and workflow automation.

Responsibilities:

• Develops individual protocol/SAP and determines appropriate statistical methodology for RWD/RWE studies.

• Analyzes large datasets from diverse sources, including claims databases, EHR, registries, and patient-reported outcomes.

• Participates in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.

• Collaborates with the statistical programming staff to ensure that all programs meet analysis and external requirements.

• Performs key and innovative part of the analyses and interprets results.

• Prepares oral and written reports to effectively communicate results.

• Reviews stat related documents during projects initiation, conduct and reporting when external vendors involved.

• Is involved in research activities for innovative statistical methods and applications.

• Prepares materials and conducts training to internal/external audience in venue initiated by MA and commercial.

• 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:

• 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.

• Advanced proficiency in relational databases and programming languages such as R, Python, SAS, or SQL in big data environment.

• Advanced knowledge in Real-World Data (RWD), HEOR, and Epidemiologic methodology, including study design, statistical analysis and interpretation.

• Demonstrates interest in statistical research activities and application of novel methods to clinical trial development and RWE.

• Basic good presentation, oral and written communication skills.

• Ability to learn, being proactive, motivated, and consistently focus on details and execution.

• 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.