Senior/Principal Clinical Statistical Programmer

About the Position

With its Branch office in Ukraine, Poland, and Romania, Intego Clinical is looking for experienced Senior/Principal Clinical Statistical Programmers to join their 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.

Responsibilities

• 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).

Requirements

• A minimum of a Bachelor’s degree in Computer Science, Mathematics, Statistics, Pharmaceutical 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.
• 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.

We Offer

• Opportunity to work with a global team in Ukraine, Poland, and Romania.
• Be part of a leading company in the clinical trial data analysis and software development field.
• Competitive career growth and development opportunities.

About the Company

Intego Clinical is a leading company in the clinical trial data analysis and software development field, with a strong presence in Ukraine, Poland, and Romania.