Statistical Programmer

見る: 165

更新日: 16-11-2025

場所: Ghent East Flanders

カテゴリー: IT-ソフトウェア IT-ハードウェア/ネットワーキング情報技術

業界:

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仕事内容

Key Accountabilities/Responsibilities:

The Statistical Programmer is responsible for all statistical programming activities. These responsibilities include:

Provide relevant input in the development of the statistical analysis plan and mock tables, listings and figures.
Perform critical review of derived datasets specifications and derived datasets (ADaM).
Develop programs to perform QC of statistical outputs.
Define program specific standards for ADaM datasets. Check compliance of CRO delivered ADaM datasets to CDISC standards.
Verify define.xml (for ADaM’s) and ADRG.
Develop, validate and document programs for additional post-hoc analyses.
Develop, review, document and perform validation of generic SAS macros, and create a macro library.
Support data submission activities according to regulatory guidelines (e.g. ISS, ISE).
Support outsourcing programming activities and oversees the QC of these activities.
Proactively plan and coordinate all programming related activities.
Is able to independently manage programming activities for 1 or 2 studies and integrated summaries within 1 project simultaneously.
Take responsibility to deliver a project in time.
Ability to negotiate timelines and assess when extra resources are needed and communicate this proactively.

Desired Skills and Experience:

Excellent knowledge of SAS is a must. Knowledge in R is a plus.
Thorough knowledge of and experience with CDISC standards is desired.
Demonstrate ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
Display good communication skills and proficiency to work independently and as part of a team.
Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
Minimum of 8-10 years of professional experience desired.
Experience in managing CROs and vendors is a plus.
Biotech experience is a plus.

Offer:

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