Statistical Programmer

☞ Argenx

전망: 165

갱신일: 16-11-2025

위치: Ghent East Flanders

범주: IT-소프트웨어 IT-하드웨어 / 네트워킹 정보 기술

산업:

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작업 내용

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:

  • A competitive salary package with benefits;

  • A work environment in a human-sized, dynamic, rapidly growing biotech company

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마감 시간: 31-12-2025

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