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OPERATIONS - ENGINEERING/PRODUCTION
Clinical Statistical Programmer
Permanent contract
AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.
As a Clinical Statistical Programmer, you provide statistical programming expertise to deliver high-quality programs and outputs for analysis of clinical data. It is your responsibility to provide high-quality analysis results on time to support efficient decision making.
What are your responsibilities ?
Develop Analysis Data Model (ADaM) datasets Develop Tables, Figures and Listings / Output and Programming Specification (TFL/OPS) from the Statistical Analysis Plan (SAP) or a related document Develop Define.xml and Analysis Data Reviewer’s Guide (ADRG) for data submission Program and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R function/package following good programming practices Act as a statistical programming representative within cross-functional study teams and project subteams and provide statistical support and solutions Provide input to internal process improvements and/or new statistical programming capabilities Maintain current scientific and regulatory knowledge.
Life sciences
What skills do you bring to the table ?
Bsc. in Statistics, Mathematics, Informatics or equivalent At least 2 years of experience as a statistical programmer in the pharmaceutical industry Proficient in English (oral and written) Good programming skills in SAS (Macro, Structured Query Language (SQL)) and R (function,package) Able to develop, validate and maintain programs Basic knowledge of statistical concept and statistics applied to non-clinical, pre-clinical and clinical data Basic knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines Good communication skills, able to build good relationships with internal and external stakeholders Team player, able to work in a multidisciplinary team Able to manage, drive and meet delivery timelines
Technical knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards (ADaM, Study Data Tabulation Model (SDTM))
What’s the offer you can’t refuse?
As an Akkodis Team Member, you will be:
• Onboarded in your position via a buddy process
• Supported in your career by your Business Manager
• Actor of your training plan and your personal and professional development
• Benefiting from a permanent contract
• Benefiting from a competitive salary package including several extra-legal benefits
Do you any questions? You can contact me at aswah.fawad@akkodis.co
Europe, Belgium
1 to 3 years