Contract Duration: 12 Month for 1 FTE
My client, a leading global CRO, are seeking a Freelance Biostatistician (RWE) to join their team. As an experienced Biostatistician in their Consulting business supporting the Real-World Evidence (RWE) service, you will be central to the successful delivery of complex RWE studies for renowned, innovative and global top pharmaceutical and biotech companies. You will have the opportunity to lead RWE studies and support post-market regulatory submissions and publications.
In this role you will develop and review Statistical Analysis Plans (SAPs) for data presentation, analyses, and provide SAS programming oversight.
Your Responsibilities
- Lead complex RWE studies and multi-protocol programs, coordinating activities across multiple locations
- Provide statistical oversight, attend relevant project meetings, and ensure the quality of deliverables
- Develop and review Statistical Analysis Plans (SAPs) for data presentation and analyses, ensuring compliance with regulatory and scientific standards
- Oversee SAS programming and conduct senior reviews of SAPs developed by other statisticians
- Review Tables, Figures, and Listings (TFLs) for complex studies before client delivery.
- Collaborate with data management teams to implement and review Case Report Forms and study-specific specifications
- Develop statistical sections of study protocols for complex observational studies.
- Mentor and train junior staff, providing guidance to ensure accuracy and adherence to departmental policies
- Share expertise at internal meetings, scientific conferences, and bid defense meetings
- Act as a Subject Matter Expert (SME) in biostatistics, contributing to procedural documents and new initiatives
Your Profile
- Advanced degree (Ph.D. preferred) in biostatistics, computer sciences, or a related field
- 5+ years of experience as a Lead Biostatistician in biotech, CRO, or pharmaceutical companies
- Proficiency in SAS programming, including statistical procedures such as non-parametric analysis, linear and non-linear models, categorical data, and survival analysis
- Strong knowledge of SDTMs, ADaM datasets, and TFLs
- Proven ability to communicate statistical concepts effectively to diverse stakeholders
- Solid understanding of observational study processes and statistical methodologies
- Experience developing SAPs, conducting analyses, and producing high-quality reports
- Strong organizational skills, attention to detail, and ability to work both independently and collaboratively
- Business fluency in English (both written and verbal) is required
