Senior Clinical Statistical Programmer

About the Position

We are seeking a Senior Clinical Statistical Programmer with 5+ years of SAS programming and 3 years of clinical trial experience to join our team in Ukraine.

Senior Clinical Statistical Programmer provides end-to-end statistical programming support in planning, specifying, designing, developing, and implementing statistical solutions for the reporting and analysis of clinical trials in accordance with applicable processes.

As a part of existing teams, you will focus on bringing together best-in-class science, technology, and service to drive superior clinical outcome results.

Responsibilities

• Apply 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.
• Design data warehouse, SCS, and SCE databases.
• Demonstrate the use, creativity, and ingenuity to solve complex programming problems (e.g., creates reusable code, develop project/department standard code, design interconnected programs).
• Accountable for overall timelines and major project milestones, as well as overall project quality, integrity, and productivity.
• Serve on or lead departmental initiatives, specialized projects, and/or working groups.
• Serve as a project team leader.
• Develop and maintain software development tools and standard templates.
• Act as a Subject Matter Expert (SME) as a technology troubleshooter.

Requirements

• 5+ years of SAS programming experience combined with 3 years of clinical trial experience.
• Knowledge and application of p-values, confidence intervals, linear regression analysis, advanced general linear models, frequencies, survival analysis, non-parametric analysis, and randomization software.
• Proficiency in implementing new ideas in clear, efficient SAS code for the purposes of data analysis and reporting.
• Intermediate knowledge of UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory.
• Basic understanding of the FDA/ICH guidelines, the software development life cycle, 21 CFR Part 11, and other relevant FDA regulations.
• Experience working on FDA submissions is an asset.
• Understanding of the role of all the functional areas in the clinical trial process.
• Clear and timely written and verbal communication with peers, customers, and management.
• Ability to present effective presentations to small groups such as Project Teams or during Statistical Programming meetings.

We Offer

• Opportunity to work in a dynamic and innovative environment.
• Be part of a team that drives superior clinical outcome results.
• Professional growth and development opportunities.

About the Company

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