Principal Biostatistician - Biopharma - AL Solutions

George Higginson is currently searching for an experienced Principal Biostatistician. He is partnering with a commercial biopharmaceutical company working heavily across the Oncology, Inflammation and Autoimmunity space.

Main Responsibilities:

• Interact with members of the multidisciplinary project teams to establish project timelines.
• Provide statistical input to study protocols.
• Write statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Assist in writing relevant sections of the clinical study report.
• Participate and contribute to authoring of Clinical Development Plan.
• Participate in pre-IND and NDA activities.
• Participate in the development and enforcement of SOPs and guidelines.
• Other responsibilities as required.

Requirements:

• Ph.D. degree in statistics required.
• 3-5 years of experience in pharmaceutical/biotechnology/CRO industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
• History working independently in project management and decision making.
• Experienced across Phases I-III.
• Ability to use SAS to perform efficacy analyses, validating data derivations when necessary.
• Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
• Knowledge of multivariate analyses and Biomarker analyses is a plus.

How To Apply:

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.

George Higginson

Senior Associate

AL Solutions

george@alsolutions.co.uk