Job Description

The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies. The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and company standards, and maintain statistical, as well as operational, integrity throughout the life of the study. The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also collaborates with the Study Statistician, who handles operational activities related to statistical deliverables. The SLS is responsible for the integrity and quality of their study and supports product-level activities, including Regulatory submissions and publication work. Responsibilities : Provide statistical guidance, review, and contribute to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; and other key-study related documentation, protocol deviations, data quality reviews, and communications. Attend and contribute to Clinical Study Team Meetings. Participate in cross-functional study start-up activities, including CRF development, database specifications review, database development, and IVRS specifications review. Initiate and lead cross-functional team meetings as necessary (e.g., SAP review, TFL shell review). Provide statistical guidance, review, and be responsible for the analysis of individual studies/projects. Perform and document QC of primary and key secondary endpoints within ADaM datasets and their statistical analyses. Coordinate creation of outputs for Dose Level Review Meetings (DLRMs) and participate in these meetings. Review TFLs created by statistical programming for consistency and accuracy. Author analysis reports such as Flash Memo and results sections of CSRs. Collaborate with the study programming team for deliverables. Manage timelines for all statistics-related deliverables in coordination with team members. Ensure familiarity with all relevant Company policies, SOPs, and controlled documents. Assist with study and systems audits conducted by Company GCA and external bodies. Requirements / Qualifications : Master's degree in Statistics/Biostatistics or related field with at least 4 years of post-graduate statistical experience in the pharmaceutical or medical research industry, or PhD with at least 3 years of experience. Strong communication skills in both written and oral English. Deep understanding of statistical concepts related to clinical study design and conduct. Ability to apply statistical methodologies effectively in clinical trial analysis. Leadership experience in designing, analyzing, and reporting at least one complex or multiple less complex studies. Experience in protocol and SAP development, and CSR review. Proficiency in SAS and/or R programming for simulations and complex study design analyses. Preferred Qualifications : Advanced degrees (e.g., PhD or 6+ years of experience) in Statistics/Biostatistics. Experience in designing, analyzing, and reporting clinical trials in industry, government, or academia. Ability to present and defend statistical findings to diverse audiences. Leadership of at least 3 clinical studies/projects end-to-end. Experience across the drug development lifecycle. Proven ability to influence decision-making and work in cross-functional teams. Experience with adaptive trial designs and Bayesian statistics. Proficiency in R programming for complex analyses. #J-18808-Ljbffr Emendata

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