We are looking for a Senior Clinical Statistical Programmer to join our team at Akkodis UAE in Dubai. This is an onsite opportunity where you will provide statistical programming expertise to deliver high-quality programs and outputs for clinical data analysis. In this role, you will be responsible for ensuring analysis results are delivered on time to support efficient decision-making.
Key Responsibilities
- 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 SAS macros or 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.
Requirements
- 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 SAS (Macro, SQL) and R (function, package).
- Standards: Advanced knowledge of CDISC standards (ADAM, SDTM) and strong ADaM/metadata writing skills.
- Regulatory Knowledge: Solid understanding of GCP and ICH guidelines, as well as statistical concepts applied to non-clinical, pre-clinical, and clinical data.
- Professionalism: Excellent communication skills, a team-player mindset, and the ability to meet strict delivery timelines.
- Process Mastery: A good understanding of standardization and automation processes.
Location & Work Mode
- Location: Dubai, UAE.
- Work Mode: Onsite.
Join Akkodis and apply your expertise to drive high-quality clinical analysis and innovation.
