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Statistical Analyst
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As a Biostatistics Specialist focusing on Non-Interventional Studies (NIS) and Real-World Evidence (RWE), you will play a crucial role in the statistical analysis and interpretation of data within the healthcare sector.
Key Responsibilities:
- Oversee the statistical components of study protocols, reports, and publications, ensuring the quality and accuracy of statistical outputs.
- Provide guidance on statistical methodologies, including sample size determination and study design considerations.
- Develop Statistical Analysis Plans (SAPs) and create clear mock-up displays for tables, listings, graphs, and figures.
- Engage in the verification and quality assurance of analyses, confirming that results align with the SAP specifications.
- Review electronic case report forms (eCRFs) and database designs to ensure compliance with protocol requirements and comprehensive data capture.
- Adhere to relevant Standard Operating Procedures (SOPs) and regulatory standards (e.g., ICH).
- Complete assigned tasks within established timelines.
Qualifications:
- A minimum of 3 years of experience in biostatistics or a related field.
- Experience with epidemiological and/or non-interventional studies in a contract research organization (CRO), biotechnology, or pharmaceutical environment is preferred.
- Strong understanding of statistical techniques commonly applied in non-interventional research.
- In-depth knowledge of regulatory standards (e.g., FDA, EMA) and industry practices.
- Proficient in Microsoft Word, Excel, PowerPoint, and general internet applications.
- Detail-oriented with a strong focus on results.
- Demonstrated reliability and a high level of responsibility.
- Excellent written and verbal communication abilities.
- Fluency in English, both written and spoken.