Senior Biostatistician

Description:

This role plays a pivotal part within my clients Biostatistics division. With multiple clinical programmes spanning several therapeutic areas with a fantastic pipeline this role can offer a multitude of development opportunities for the right person.

Essential Duties and Responsibilities:

• Craft statistical sections in protocols.
• Design and refine studies.
• Calculate sample sizes.
• Enhance Case Report Forms (CRFs).
• Review critical Edit Check Documents like RECIST 1.1.
• Develop randomization specifications and oversee activities with the IWRS vendor.
• Author Statistical Analysis Plans.
• Conduct Statistical Analysis (efficacy and key safety) using SAS.
• Present and defend analyses at IDMC meetings.

Requirements:

• PhD in Statistics with 5+ years' pharma/CRO experience OR Master's with 5+ years' relevant industry experience.
• Proficiency in SAS, CDISC, ICH guidelines.
• Fluent in English.