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Clinical Statistical Programmer

Akkodis
Dubai, UAE
Full Time
Senior
Onsite
3 weeks ago
RADaMSDTMCDISC StandardsStatistical ProgrammingClinical Data Analysis
Free

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Job Overview

  • 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

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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