Senior Clinical Statistical Programmer
Job Description, Responsibilities & Requirements
About the Position
Intego Group, with branch offices in Warsaw, Poland, Kyiv, and Kharkiv, Ukraine, is seeking experienced Senior Clinical Statistical Programmers to join our global team. This role can be based in our offices or worked remotely.
As a member of the clinical project team, the Senior Clinical Statistical Programmer will apply advanced programming techniques and leadership to the 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 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.
Requirements
- A minimum of a Bachelor’s degree in Computer Science, Mathematics, Statistics, Pharmaceutical Sciences, Life Sciences, or 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.
- Excellent knowledge of SAS programming and associated features and their applications in the pharmaceutical 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 experience 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 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.
We Offer
- Opportunity to work with a global team from our offices or remotely.
- Competitive compensation package.
- Professional development opportunities.
About the Company
At Intego Group, we value all employees and job candidates as unique individuals, and we welcome the variety of experiences they bring to our company. We have a strict non-discrimination policy and believe everyone should be treated equally regardless of race, sex, gender identification, sexual orientation, national origin, native language, religion, age, disability, marital status, citizenship, pregnancy, or any other characteristic protected by law.