Principal Biostatistician

Senior or Principal Biostatistician - CRO - UK/Remote

Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.

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-art 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? xwzovoh Drop me a message or send your CV to receive more details surrounding this role and discuss this further!