With its Branch office in Ukraine, Poland and Romania, Intego Clinical is looking for experienced Senior/Principal Clinical Statistical Programmers to join the our global team!  

As a clinical project team member, the Senior/Principal 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. 

Location: Romania 

Job responsibilities: 

The Senior/Principal 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. 

• Responsible for the processing of clinical data required for analysis of clinical trials for Phase 1-4. 
• Develop SAS coding and table templates for preparing, processing, and analyzing clinical data. 
• Generate and QC summary tables, data listings, and graphs for in-house analyses of study data or publications using SAS standard coding practices. 
• Create/acquire tools to improve programming efficiency or quality. 
• Validate the work of other programmers/analysts. 
• Create/review programming plan, specifications for datasets, and TLF's. 
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. 
• Support data queries from other functional groups (Biostatistics, Medical Writing, Clinical Development, Clinical Operations, Regulatory, and Marketing). 

General requirements: 

• A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences, and related areas is required. A Master's is preferred 
• A minimum of 5 years of hands-on relevant career experience in the pharmaceutical or biotechnology industry 
• Have excellent knowledge of SAS programming and associated features and their applications in the pharmaceuticals industry environment, particularly clinical trial data sets 
• Familiar with CDISC conventions, i.e., SDTM and ADaM models, and hands-on experience implementing these models 
• Strong understanding of clinical trial data and hands-on in data manipulations, analysis, and reporting of analysis results 
• Must understand the role of all the functional areas in the clinical trial process 
• Must have a basic understanding of the FDA/ICH guidelines, the software development life cycle, 21 CFR Part 11, and other relevant FDA regulations 
• 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 
• Must demonstrate intermediate UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory 
• Track record of generating new ideas and solutions to data analysis 
• Excellent application development skills 
• Thorough understanding of relational database components and theory 
• SAS certification is an advantage 
• It would be an asset to have had experience working on FDA submissions 
• The candidate should demonstrate clear and timely written and verbal communication with peers, customers, and management 
• Should be able to present effective presentations to small groups such as Project Teams or during Statistical Programming meetings