Clinical Statistical Programmer
Akkodis
DubaiOn-siteFull-Time2w ago
Description
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 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.
Required Skills & Experience (Must-Haves)
- 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.
Preferred Skills & Experience (Nice-to-Haves)
- 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.
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