Senior Biostatistics Lead

Parexel is on the lookout for a Senior Biostatistics Lead to join our team for a remote position. In this pivotal role, you will independently manage complex clinical trial projects, often showcasing a significant regulatory impact. As a recognized statistical expert, your contributions will be highly valued both internally and externally. Key Responsibilities: Deliver comprehensive statistical support across various studies, including the design, protocol development, and CRF creation. Oversee the production and quality assurance of randomization, analysis plans, statistical reports, and related documentation. Conduct sample-size calculations, create randomization lists, and draft statistical methodology sections for study protocols. Provide statistical insights for Data Monitoring Committee (DMC) activities, including the development of charters and analysis plans. Act as a non-voting independent statistician, offering data and analytical support for DMC reviews. Business Development: Assist in business development efforts by contributing to study design discussions during internal and client meetings, supporting sample size considerations, budget proposals, and participating in bid defense meetings. General Activities: Stay informed about regulatory requirements in specific therapeutic areas and their implications for statistical analysis. Implement and train others on advanced statistical methods and novel techniques. Help create and lead internal and external statistical training seminars and workshops. Review position papers based on prevailing good statistical practices. Engage with clients and regulatory bodies on statistical matters. Analyze publications and clinical study reports for quality assurance and compliance. Travel as necessary to client meetings to present analysis concepts and discuss study outcomes. Perform additional responsibilities as assigned by management. Required Skills: Strong analytical and project management capabilities. A professional and detail-oriented approach to work. Deep understanding of statistical challenges in clinical trial settings. Ability to clearly explain advanced statistical techniques and interpret data results. Familiarity with regulatory and research guidelines related to drug development, including GCP and statistical principles, especially ICH guidelines. Experience with SAS programming is essential. Capability to work autonomously with strong mentoring and leadership skills. Sound business awareness and ability to support business development initiatives. Knowledge and Experience: PhD or MS in Statistics or a related field with considerable experience. Understanding of pharmacokinetic data is advantageous. Proficiency in written and oral English, as well as local language skills. Education: PhD in Statistics or related discipline, or MS in Statistics or related discipline. Parexel is an equal opportunity employer, ensuring qualified applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Created: 2026-03-04