Job Description
Biostatistician for Non-interventional studies (NIS) /
Real-World Evidence (RWE)

Tasks & Responsibilities: 
• Responsible for the statistical aspects of the protocol, study report and publications, ensuring quality and integrity of statistical deliverables.
• Provides expertise on statistical methodology, sample size calculations, and study design.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, graphs, and figures. 
• Conducts and participates in verification and quality control of analysis, ensuring that output meets expectations and is consistent with analysis described in SAP.
• Reviews electronic case report forms (eCRFs), database design to ensure protocol criteria are met and all data is captured as required to perform the planned analysis.
• Follows applicable Standard Operating Procedures (SOPs), and relevant regulatory guidelines (e.g. ICH).
• Completes assigned tasks within agreed timelines.

Required education and experience: 
• Minimum of 3 years of experience as a Biostatistician or a related discipline.
• Experience in epidemiological and/or non-interventional studies within a CRO, biotech or pharmaceutical company preferred.
• Solid understanding of statistical methods commonly used in non-interventional studies.
• Profound knowledge of regulatory guidelines (e.g., FDA, EMA) and industry standards
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Structured and careful way of working, high result orientation.
• Reliability and high sense of responsibility.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.