Job Description, Responsibilities & Requirements
About the Position
With its Branch office in Armenia, 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, 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.
- 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 join a global team.
- Work in a branch office in Armenia.
- Competitive salary and benefits.
About the Company
Intego Clinical is a leading company in the pharmaceutical industry, dedicated to providing innovative solutions for clinical trials and data analysis.