Interim RWE Biostatistician

We are currently partnered with a global leading Clinical Research Organisation who are seeking a skilled and experienced Interim RWE Biostatistician to join their dynamic team. In this role, you will apply your expertise in biostatistics and real-world evidence to deliver high-quality statistical analyses that drive insights and innovation in healthcare research. This is an exciting opportunity for a talented professional to contribute to impactful projects and collaborate with multidisciplinary teams.

Key Responsibilities:

• Manage complex studies or multi-protocol programs, ensuring coordination across multiple sites, providing statistical guidance, and participating in relevant project meetings.
• Oversee project management tasks for designated projects, including resource allocation, timeline planning, and milestone tracking.
• Lead the creation of advanced Statistical Analysis Plans (SAPs) and conduct senior reviews of SAPs developed by other statisticians.
• Perform comprehensive statistical reviews of Tables, Figures, and Listings (TFLs) for complex studies before client submission.
• Collaborate with data management teams to design and evaluate Case Report Forms and other study-specific specifications, aligning them with observational study data requirements.
• Draft the statistical sections of study protocols for complex studies, guided by input from a statistical consultant.
• Mentor and train junior staff members, providing guidance and reviewing their work to ensure accuracy and adherence to departmental standards.

Qualifications and Skills:

• A minimum of 10 years of experience as a Lead Biostatistician in the biotech, CRO, or pharmaceutical industries.
• Proficiency in programming with statistical software (e.g., SAS) for conducting a wide range of analyses, including non-parametric methods, linear and non-linear models, categorical data, and survival analyses.
• Demonstrated expertise in working with SDTMs, ADaM datasets, and TFLs.
• Strong communication skills for effectively conveying statistical concepts.
• Comprehensive knowledge of the observational study process.
• Proven ability to prepare SAPs, conduct analyses, and generate reports.
• Excellent organizational skills, with the ability to work independently and collaboratively, a curious mindset, and a strong attention to detail.
• Fluency in English, both written and spoken, is essential.