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Malt Strategy
Amine K.AK

Amine K.

Principal Statistical Programmer

€600/day
Bruxelles, BE
8-15 years
SAS
R
Biostatistique
CDISC
ADAM

Average response time: 1 hour

About Amine

Je suis programmeur statistique avec plus de 13 ans d'expérience dans le domaine des essais cliniques, principalement avec le logiciel SAS. Certifié en ADaM, j'ai également de solides connaissances en CDISC et SDTM.
Pharmaceuticals
Health and Wellness

  • French

    Fluent

  • English

    Fluent

  • Arabic

    Native or bilingual

Can work on-site
Bruxelles (up to 50km)

Experience

  • Enovalife
    Principal Statistical Programmer
    September 2021 - Today (4 years and 9 months)
    Brussels, Belgium
    • Liaison between sponsor and project team for technical, timeline, quality, and contractual aspects (deal with out-of-scope activities prospectively)
    • Act as the liaison between sponsor and project team communications
    • Manage project team members with regard to the project work
    • Set up and plan the project activities in collaboration with the project team
    • Ensure the project team complies with all applicable SOPs and sponsor agreements
    • Plan for and review resourcing, timing, project quality and project budget
    • Prepare for and conduct project review meetings with team members (9 statistical programmers and 1 biostatistician from Europe and the UK)
    • Co-ordinate all project archiving activities
    • Hands-on Statistical Programming and Complex Formula Validation (30%)
    • Interviewing Statistical Programmers from different countries for contract purpose
    • Participating and presenting at PHUSE conference (Data Handling & Data Engineering (DH) stream in 2022 / Data Standards (DS) stream in 2021)
  • Business & Decision Life Sciences
    Senior Statistical Programmer
    August 2020 - August 2021 (1 year)
    Brussels, Belgium
    • Acted as lead programmer producing specifications, ADaMs, TFLs, and Define xml for respiratory disease and oncology clinical studies (phase I, phase II, phase III).
    • Trained newcomers and junior statistical programmers and prepare exercise for statistical programming
    • Redaction of Reviewer's Guide for PMDA/FDA submission
    • Generation of Pinnacle 21 report
    • Creation of SAS macros to support ISS and ISE analyses
  • Keyrus (External at GSK vaccines)
    Senior Statistical Programmer
    July 2017 - July 2020 (3 years)
    Tunis, Tunisia
    • Oversee the SAS programming and analysis functions and support for the entire epidemiological (phase IV) and clinical studies (phase I, Phase II) across protocols and statistical analysis plans (SAPs)
    • Worked with the US and India team on Respiratory Syncytial Virus (RSV) vaccination program for 3 years
    • Played a key role in developing, debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings in accordance with departmental standards
    • Generated analysis datasets based on the Data Definition Tables (DDT) and in accordance with the CDISC standard (SDTM model / ADAM for domain creation and CDISC compliant analysis datasets)
Check out Amine's experience

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Education

  • Master of Science (MSc) in Statistics and Data Analysis
    Higher School of Statistics and Data Analysis
    2012
    Statistics

Certifications

Skill set

STATISTICS
SPSS
Data science

Categories