Intego Group

Senior/Principal Clinical Statistical Programmer

USA

Intego Clinical’s office in Florida, USA, is looking for experienced Senior/Principal Clinical Statistical Programmers to join our global team working from the office or remotely.

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.

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 4 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, 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.
• 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.