Principal Biostatistician – Biomarker Analyst

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee projects spanning multiple studies or programs, serving as the main point of contact for biostatistics activities with sponsors.

• Offer external statistical consultancy and act as a departmental expert for intricate statistical inquiries, study design, and protocol formulation.

• Plan, implement, and evaluate biomarker components of clinical and biomarker studies, including genomics and devices.

• Create Biomarker Evaluation Plans and manage statistical activities related to biomarker research and development.

• Design sophisticated data analyses, statistical programming, and complex analytical algorithms for genomics and biomarker statistics.

• Generate and verify the accuracy of Biomarker Evaluation Reports and statistical outputs.

• Establish standard procedures for routine biomarker assessments.

• Mentor biostatisticians, oversee their training plans and materials, and conduct educational sessions.

• Supervise and independently review the project work of biostatistics personnel.

• Assist with statistical tasks throughout the project lifecycle, from protocol development to clinical study reporting.

• Prepare or supervise the creation of Statistical Analysis Plans, including mock-up tables, listings, and figures.

• Manage statistical components of protocols, randomization schedules, and clinical study reports as necessary.

• Create or evaluate programming specifications, SAS annotated CRFs, database designs, and study documentation.

• Perform verification and quality control on project outputs.

• Lead intricate or multiple projects, support regulatory agency meetings, and address sponsor inquiries.

• Track milestones, timelines, workloads, scope, and project deliverables.

• Provide statistical programming assistance and engage in DSMB/DMC activities.

• Adhere to SOPs, work instructions, and applicable regulatory guidelines such as ICH.

• Maintain comprehensive, up-to-date project documentation and readiness for inspection.

• Contribute to business development through proposals, budgeting, and sponsor bid defense meetings.

⛳️ Requirements

• In-depth knowledge of biomarker evaluation, especially in Oncology, ctDNA data, relevant parameters, and foundational biology.

• Advanced degree in Biostatistics or a related field.

• Significant experience in clinical trials or an equivalent combination of education and experience, evidenced by the ability to manage multiple projects and study programs.

• Proficient in R programming.

• Capability to leverage extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques used in clinical research, along with effective communication of statistical concepts.

• Experience with all statistical tasks necessary to support clinical trials throughout the entire project lifecycle, from protocol to CSR.

• Prior experience with regulatory submissions is preferred.

• Exceptional written and verbal communication abilities.

• Proficient in reading, writing, speaking, and understanding English.

🏝️ Benefits

• Career development and advancement opportunities.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Minimal travel may be necessary.