Sr. / Principal Biostatistician

Role overview

A senior-level biostatistics position responsible for providing statistical expertise and managing data services across data management, statistical services, and medical writing functions. The role spans clinical trial design, sample size determination, statistical methods, analysis population definition, interpretation of results, simulation work, and strategic and regulatory consultation. It also involves end-to-end oversight of data service activities, ensuring deliverables meet schedules, hours, and standard operating procedures while satisfying internal and client requirements.

Responsibilities

- Provide statistical input into clinical trial design, including sample size and analysis population determination. - Select and apply appropriate statistical methods and simulations, interpreting results for project teams and clients. - Manage data service activities from initiation through completion, setting clear expectations and communicating them to team members. - Estimate resource needs with management to achieve project goals. - Ensure activities adhere to relevant standard operating procedures and meet client expectations. - Offer strategic and regulatory statistical consultation across programmes.

Requirements

- Senior-level experience providing statistical expertise within clinical research or a related environment. - Strong capability in clinical trial design, sample size estimation, and selection of statistical methods. - Demonstrated ability to interpret complex statistical results for varied audiences. - Experience managing end-to-end data service workflows, including data management, statistical services, and medical writing. - Familiarity with relevant standard operating procedures and regulatory expectations. - Excellent communication and project management skills, with the ability to balance scope, schedules, and budgets.