Senior Clinical Statistical Programmer

Job responsibilities:

The Senior 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, 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