Senior / Principal Biostatistician - CRO - UK / Remote

We have recently partnered with this modern thinking, CRO, who are looking for biostatisticians to join their team, to expand their outreach in the UK / Europe.

You will need strong technical skills and also a entrepreneurial flair and the ability to offer strategic input.

Key Accountabilities

• Work with a leader of the Statistical Operations management team to manage clinical trial programs / projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs / projects.
• Provide statistical oversight on projects in the assigned drug development programs / projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
• Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program / projects.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.
• Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-arts statistical methodology and regulatory requirements.
• Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
• Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements
• Interact with regulatory agencies and support sponsor in new drug application.

Qualifications and Experience

A Ph.D. degree in statistical science, mathematical analysis or related fields

OR

A Master’s degree in the above fields

Interested? Drop me a message or send your CV to aimee@warmanobrien.com receive more details surrounding this role and discuss this further!