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Clinical Statistical Programmer

Akkodis
Dubai, UAE
fulltime
Mid-Senior
4 days ago
ClinicalProgrammerStatistical
Free

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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 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:**

Tables, Figures, and Listings (TFL And 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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