Senior Biostatistician

Our partner

A leading full-service contract research organization (CRO) is seeking a Senior Biostatisticianto join its team. With a global presence and a strong foundation in statistical and data management, the company supports a range of clients in pharmaceutical, biotechnology, and medical device with their clinical development programs.

Your responsibilities

• Provide statistical expertise for the design, analysis, and reporting of clinical trials and research projects.
• Contribute to writing statistical sections of protocols, conduct sample size calculations, develop randomization specifications, and generate codes.
• Write Statistical Analysis Plans (SAPs) and address peer statistician feedback.
• Create and maintain Statistical and Programming Quality Control (QC) and Quality Assurance (QA) Plans.
• Provide input on unblinded data management plans where necessary.
• Support the development and refinement of statistical methodologies and internal processes.

• Perform statistical analyses according to the SAP and respond to QC review comments.
• Conduct statistical validation of key results and address additional review feedback.
• Contribute to trial result dissemination meetings and documentation.
• Assist with the statistical components of Clinical Study Reports (CSRs), including writing and reviewing for accuracy and interpretation.
• Conduct statistical analyses for abstracts, manuscripts, presentations, and posters.

• Develop and/or review ADaM dataset specifications; review SDTM specifications as needed.
• Perform QC validation of datasets and tables/listings/figures (TLGs).
• Conduct third-level reviews of dry and final runs.
• Lead statistical dry and final runs, manage resources, and collaborate with programming and data management teams.
• Provide input and respond to feedback for the Analysis Data Reviewer’s Guide.

• Offer statistical input on Case Report Forms (CRFs) and variable/database structure.
• Provide guidance for non-CRF data collection methods.
• Review Data Management Plans, focusing on critical data collection and cleaning.
• Define or program database quality checks, assess/report data issues, and track to resolution.
• Monitor data quality, including protocol deviations, and support data lock preparation.
• Lead resolution of operational challenges, ensuring quality and efficiency.
• Manage assigned projects using project management and statistical expertise to deliver high-quality results on time and foster client satisfaction.

• Follow internal policies, standard operating procedures (SOPs), and sponsor work instructions.
• Archive study documentation in line with sponsor requirements.

Requirements

• A Ph.D. degree in statistical science, mathematical analysis or related fields
• 3+ years relevant biostatistical experience
• Proven ability within a clinical trial environment.