Senior Clinical Statistical Programmer
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Job description
About the Position
With its Branch office in Poland, Intego Group is looking for experienced Senior Clinical Statistical Programmers to join the global team working from the Warsaw office or remotely.
As a clinical project team member, the Senior 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 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.
We Offer
- Opportunity to work with a global team.
- Flexible work arrangements (remote or in-office).
- Professional growth and development opportunities.
About the Company
Intego Group is a leading organization in the pharmaceutical and biotechnology industry, dedicated to advancing clinical research and data analysis.
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Headquartered in the United States, Intego Group is a leading IT outsourcing and software engineering provider that specializes in full-lifecycle product development and high-end solution implementations. Leveraging deep domain expertise, a solid technology background and multi-industry experience, Intego Group provides an integrated portfolio of engineering services to clients in North America and Western Europe.Established in 1999, Intego Group employs a global delivery model through its client-facing operations in the United States and delivery centers strategically located in Ukraine. Combining comprehensive capabilities and highly skilled talent, we collaborate with our customers to build long-term partnerships based on our culture of engineering excellence and commitment to high quality.The experience and reputation we’ve built for over a decade with both clients and engineers has allowed us to differentiate our company in the market for sophisticated software engineering skills, adaptive and transparent business models, high levels of expertise, and a strong knowledge base across a variety of industries. We strongly believe that our people and methodologies are the key point of differentiation in how we deliver exceptional value to our clients and internal staff.