Principal Biostatistician

Principal Statistician

Full-Time | Permanent

Mid-sized CRO

Full-Time | Permanent

We are supporting a specialist biometrics CROin their search for a Principal Statistician to lead high-level statistical consulting and direct statistical teams across multiple clinical studies. This is a senior leadership role combining technical statistical expertise with client-facing consulting, study leadership, and business development.

Experience in neurodegenerative disease studies is preferred but not required. Strong SAS programming skills, including the development of Tables, Listings, and Figures (TFLs), are required for this role.

Key responsibilities

• Lead statistical planning and analysis across multiple clinical studies, spanning Phase I-V trials, ISS, ISE, registries, and publications
• Design data acquisition strategies, assess results, and analyse trends
• Develop and review Study Protocols and Statistical Analysis Plans
• Develop Integrated Safety Summary (ISS) and Integrated Efficacy Summary (ISE) plans
• Oversee analysis specifications through to data analysis, including TFL and Analysis Dataset Specifications
• Write the statistical sections for Clinical Study Reports, ISS, and ISE
• Represent clients at regulatory agency meetings, including the FDA
• Interface directly with senior client management
• Develop, publish, and present white papers and conference presentations
• Lead one or more studies at a client and mentor junior statisticians
• Contribute to business development as needed

What we're looking for

• Doctoral degree in Statistics required
• 15+ years of pharmaceutical or CRO industry experience
• Strong hands-on SAS programming skills, including TFL development
• Working knowledge of CDISC, SDTM, and ADaM
• Minimum 10 years of technical project management experience directing statisticians and statistical programmers
• Recognised industry authority among clients and peers
• Excellent management, interpersonal, and communication skills, with comfort interfacing with senior executives

Nice to have

Experience in neurodegenerative disease studies