With its Branch office in&nbsp;Ukraine,&nbsp;Poland&nbsp;and Romania,&nbsp;Intego&nbsp;Clinical&nbsp;is looking for experienced Senior/Principal&nbsp;Clinical Statistical Programmers to join the&nbsp;our&nbsp;global team!&nbsp;&nbsp;As a clinical project team member, the Senior/Principal&nbsp;Clinical Statistical Programmer applies advanced-level programming techniques and leadership to the planning, design, development, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials.&nbsp;&nbsp;Location:&nbsp;Romania&nbsp;Job&nbsp;responsibilities:&nbsp;The Senior/Principal&nbsp;Clinical Statistical Programmer will be responsible for overall timelines and significant project milestones, and overall project quality, integrity, and productivity. May serve on or lead a departmental initiative, specialized projects, and working groups. Can serve as a project team leader. This senior position should be capable of developing and maintaining software development tools and standard templates. Also, this person should be a Subject Matter Expert (SME) as a technology troubleshooter.&nbsp;<ul><li>Responsible for the processing of clinical data required for analysis of clinical trials for Phase 1-4.&nbsp;</li><li>Develop SAS coding and table templates for preparing, processing, and analyzing clinical data.&nbsp;</li><li>Generate and QC summary tables, data listings, and graphs for in-house analyses of study data or publications using SAS standard coding practices.&nbsp;</li><li>Create/acquire tools to improve programming efficiency or quality.&nbsp;</li><li>Validate the work of other programmers/analysts.&nbsp;</li><li>Create/review programming plan, specifications for datasets, and TLF's.&nbsp;</li><li>Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.&nbsp;</li><li>Support data queries from other functional groups (Biostatistics, Medical Writing, Clinical Development, Clinical Operations, Regulatory, and Marketing).&nbsp;</li></ul>&nbsp;General&nbsp;requirements:&nbsp;<ul><li>A minimum of a&nbsp;Bachelor's degree in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences, and related areas is required. A&nbsp;Master's&nbsp;is preferred&nbsp;</li><li>A minimum of&nbsp;5&nbsp;years of hands-on relevant career experience in the pharmaceutical or biotechnology industry&nbsp;</li><li>Have excellent knowledge of SAS programming and associated features and their applications in the pharmaceuticals industry environment, particularly clinical trial data sets&nbsp;</li><li>Familiar with CDISC conventions, i.e., SDTM and&nbsp;ADaM&nbsp;models, and hands-on experience implementing these models&nbsp;</li><li>Strong understanding of clinical trial data and hands-on in data manipulations, analysis, and reporting of analysis results&nbsp;</li><li>Must understand the role of all the functional areas in the clinical trial process&nbsp;</li><li>Must have a basic understanding of the FDA/ICH guidelines, the software development life cycle, 21 CFR Part 11, and other relevant FDA regulations&nbsp;</li><li>Must possess the knowledge and application of p-values, confidence intervals, linear regression analysis, advanced general linear models, frequencies, survival analysis, non-parametric analysis, and randomization software, and demonstrate proficiency in implementing new ideas in clear, efficient SAS code for the purposes of data analysis and reporting&nbsp;</li><li>Must demonstrate intermediate UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory&nbsp;</li><li>Track record of generating new ideas and solutions to data analysis&nbsp;</li><li>Excellent application development skills&nbsp;</li><li>Thorough understanding of relational database components and theory&nbsp;</li><li>SAS certification is an advantage&nbsp;</li><li>It would be an asset to have had experience working on FDA submissions&nbsp;</li><li>The candidate should demonstrate clear and timely written and verbal communication with peers, customers, and management&nbsp;</li><li>Should be able to present effective presentations to small groups such as Project Teams or during Statistical Programming meetings&nbsp;</li></ul>

Intego Clinical is a global biometrics and data science clinical research organization (CRO) supporting pharmaceutical and biotechnology companies with reliable, submission-ready clinical data and statistical outputs. Our team brings deep expertise in statistical programming, biostatistics, data management, and regulatory submission support for Phase I-IV clinical studies across multiple therapeutic areas. We support both project-based outsourcing and Functional Service Provider (FSP) models, either taking full responsibility for biometrics study deliverables or providing dedicated teams embedded within sponsor processes and standards. For emerging biotech companies, Intego Clinical can function as an external biometrics department, managing study delivery and regulatory outputs without the need to build internal infrastructure or hire a biometrics team. The company’s strategy is to achieve reliable global delivery across multiple time zones, maximizing responsiveness, effective collaboration, and timeline predictability. We have deliberately expanded our R&D centers worldwide across Europe, LATAM, and the US, giving our clients reliable access to specialized talent, scalable capacity, operational resilience, cost efficiency, and continuous support throughout the project lifecycle as a long-term biometrics CRO partner.

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