Principal Statistical Programmer

23 hours ago

Bridgewater, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
Job Summary

As a Principal Statistical Programmer at Katalyst Healthcares & Life Sciences, you will play a key role in developing and maintaining clinical trial data and statistical programming standards. You will be responsible for performing hands-on primary statistical programming and validation programming on assigned projects, including phase I – IV clinical trials, integrated clinical summaries, and responses to requests from regulatory agencies. You will also create SDTM mapping specifications and ADaM data specifications, and perform quality control (QC) review of these documents prepared by others. Additionally, you will create SDTM and ADaM define.xml files, and perform 3rd level QC review on programming deliverables before their release to clients. You will also participate in statistical programming project bidding or bid defense meetings, and work with document management specialists/archivists to plan and perform archival of statistical programming datasets, outputs, documents, and final programs upon the completion of assigned projects.

Requirements

M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
An in-depth knowledge of clinical trial data processing and manipulation, hands-on statistical programming and analysis, and requirements for assembling and presenting trial results to regulatory agencies.
Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented.
Knowledge of clinical trial regulatory and ICH requirements.
Ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.
In-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to relevant functions and operations.
Sound technical judgment and experience in process design and implementation in relevant areas.
Strong leadership and drive to achieve goals.

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