Statistical Programmer

1. GENERAL INFORMATION

Function: Statistical Programmer

2. PURPOSE OF THE FUNCTION

• The Statistical Programmer collaborates with the Biostatistician and the project team on clinical development programs within argenx.
• Supports submission activities and facilitates near-real-time data availability and analysis to build a data-driven knowledge base on argenx’s compounds and patient populations.
• Programs statistical analysis datasets and outputs, and performs quality control (QC) thereof.
• Ensures CDISC and regulatory compliance across deliverables.
• Provides programming support to other functional areas such as data acquisition, regulatory, global safety, and medical.
• Designs, builds, and improves the statistical programming environment and contributes to innovation initiatives.
• Participates in tool development and validation of reusable macros.
• Provides input on standardization and automation across studies and programs.

3. REPORTING LINE

• Technical or Project Programming Team Lead

4. ROLES AND RESPONSIBILITIES

• Oversight of ADaM datasets and statistical outputs, including integrated analyses (ISS, ISI, ISE).
• Perform lean, targeted QC of CRO deliverables and ensure compliance with CDISC ADaM standards and regulatory expectations.
• Provide input into CRF development, statistical analysis plans, and mock TLFs.
• Assist in tool and process development for the programming environment.
• Define study-specific ADaM dataset standards and verify compliance.
• Perform QC on define.xml files and ADRGs.
• Validate and document generic and study-specific SAS macros.
• Participate in cross-functional project team meetings.
• Support data submission activities aligned with regulatory guidelines (e.g. ISS, ISE).
• Act as a collaborative team member in a globally distributed environment.

5. SKILLS AND COMPETENCIES

• Excellent SAS programming skills; experience with R is a plus.
• Strong knowledge and application of CDISC standards, particularly ADaM.
• Ability to independently plan and execute statistical programming tasks across multiple studies and programs.
• Good communication skills and the ability to work effectively in a remote, collaborative team.
• Familiarity with ICH-GCP, clinical trial data, and regulatory expectations.
• Experience working with and overseeing CRO deliverables is an advantage.

6. EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree or higher in Science, Statistics, Information Technology or a related field.
• Minimum of 3–4 years of professional programming experience, ideally in biotech or pharma.
• Strong experience in SAS; knowledge of R is beneficial.
• Experience managing external vendors or CROs is a plus.