Job Title

Our partnerA leading full-service contract research organization (CRO) is seeking a Senior Biostatistician to 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 experienceProven ability within a clinical trial environment.