Clinical Statistical Programmer

Job Description

In this role, you will be responsible for ensuring analysis results are delivered on time to support efficient decision-making

• Dataset Development: Develop Analysis Data Model (ADaM) datasets.
• Outputs & Specifications: Develop Tables, Figures, and Listings (TFL/OPS) from the Statistical Analysis Plan (SAP).
• Submission Readiness: Develop Define.xml and the Analysis Data Reviewer's Guide (ADRG) for data submission.
• Programming & Validation: Program and validate standard ADaM and utility R functions/packages.
• Strategic Support: Act as a statistical programming representative within cross-functional study teams and project sub-teams.
• Continuous Improvement: Provide input to internal process improvements and maintain current scientific and regulatory knowledge.

• Education: Bsc. in Statistics, Mathematics, Informatics, or an equivalent field.
• Experience: At least 5 years of experience as a statistical programmer within the pharmaceutical industry.
• Technical Skills: Advanced programming skills in R (functions and packages) are mandatory.
• Standards: Advanced knowledge of CDISC standards (ADaM, SDTM) and strong ADaM/metadata writing skills.
• Compliance: Solid understanding of GCP and ICH guidelines, as well as statistical concepts applied to clinical data.
• Professional Attributes: Excellent communication skills, a team-player mindset, and the ability to meet strict delivery timelines.
• Domain Expertise: We are shifting our focus to support pharmaceutical projects.

• Therapeutic Focus: Experience in oncology is highly preferred
• Legacy Tools: Knowledge of SAS (Macro, SQL) is considered a plus, though it is no longer required.