Вакансия Senior Clinical Statistical Programmer

Skills

• SAS
• Unix
• Oracle Clinical

Описание вакансии

Intego Group is looking for experienced Senior Clinical Statistical Programmers to join the global team working from our offices or remotely.
As a clinical project team member, the Senior Clinical Statistical Programmer applies advanced-level programming techniques and leadership to reporting and analysis of clinical trials.
The Senior Clinical Statistical Programmer will be responsible for overall timelines, 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. Also, this person should be a Subject Matter Expert (SME) as a technology troubleshooter.

Job responsibilities:

• Responsible for the processing of clinical data required for analysis of clinical trials for Phase 1-4.
• Develop SAS code 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.

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 basic knowledge of statistics such as 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.