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.
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.
* Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.
* 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.
* Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
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!