SENIOR CLINICAL SAS PROGRAMMER

Who We AreWe are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people’s health worldwide by providing accessible, effective, safe, and quality medicines through our various business units, underpinned by continuous investment in R&D and cutting-edge technology at all our centers.Job Description: Statistical ProgrammerThe Statistical Programmer is responsible for programming and verifying Clinical Trial Data to produce high-quality deliverables that meet study timelines, quality standards, and requirements. This role works closely and communicates effectively with internal team members and statisticians to best serve the deliverable needs.Responsibilities:Provide Statistical Programming support by producing or verifying SAS scripts and outputs for Analysis Files, Tables, Listings, Figures, and any other form of Clinical Trials.Support the development and review of SDTM and ADAM data specifications.Generate and validate statistical analyses (tables, listings, and figures) using SAS and other software.Assist in the development of the data analysis plan, coordinate the programming and data management process with the internal team, review statistical deliverables, ensure the quality of deliverables, and act as an integral member of the clinical operations team.Regularly interact with other team members within operations to prevent potential issues and/or reconcile them if they occur.Maintain overall awareness in the field of statistical programming through self-training, attending training classes/conferences, and keeping current professional knowledge in a broad range of clinical research.Perform validation and quality review of deliverables provided by internal or external resources.Support Regulatory Affairs with electronic submissions to the FDA by preparing documents under the CRT folder in compliance with eCTD guidelines.Review programming and data management-related documents (e.g., case report form (CRF) design, CRF annotation, edit checks, database structure).Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company’s standards are up to date and in line with industry standards, conventions, and regulatory requirements.Qualifications:Bachelor’s degree in statistics, mathematics, or a related field, or its international equivalent.Minimum of 5 years of experience in programming and analyzing clinical trial data in a clinical research organization (CRO), pharmaceutical, or biotechnology industries.Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.Ability to demonstrate extensive knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.Additional Requirements:Some travel may be required.Competencies:Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.Excellent communication and interpersonal skills to effectively interface with others.