Lead Biostatistician for Non-Interventional Research

1 month ago


Beijing, Beijing, China Ipsos Full time
Position Overview:
As a Senior Biostatistician specializing in Non-Interventional Studies (NIS) and Real-World Evidence (RWE), you will play a crucial role in the statistical analysis and reporting of healthcare research.

Key Responsibilities:
  • Oversee the statistical components of research protocols, study reports, and publications, ensuring the highest quality and integrity of statistical outputs.
  • Offer expert guidance on statistical methodologies, including sample size determinations and study frameworks.
  • Develop comprehensive Statistical Analysis Plans (SAPs), featuring well-structured mock-up displays for tables, listings, graphs, and figures.
  • Engage in the verification and quality assurance of analyses, confirming that results align with expectations and adhere to the SAP.
  • Review electronic case report forms (eCRFs) and database designs to ensure compliance with protocol requirements and comprehensive data capture for planned analyses.
  • Adhere to established Standard Operating Procedures (SOPs) and relevant regulatory standards (e.g., ICH).
  • Complete assigned responsibilities within specified timelines.

Qualifications:
  • A minimum of 3 years of experience in a Biostatistics role or a related field.
  • Background in epidemiological and/or non-interventional studies within a Contract Research Organization (CRO), biotechnology, or pharmaceutical sector is preferred.
  • Strong grasp of statistical techniques commonly applied in non-interventional research.
  • In-depth knowledge of regulatory frameworks (e.g., FDA, EMA) and industry best practices.
  • Proficient in Microsoft Word, Excel, PowerPoint, and general internet applications.
  • Demonstrated structured approach to work with a strong focus on results.
  • High reliability and a strong sense of accountability.
  • Exceptional written and verbal communication abilities.
  • Proficiency in reading, writing, speaking, and understanding English.

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