Descrizione:
Senior Clinical Statistical ProgrammerOur mission is clear at Akkodis: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.
With our 360° offer we support companies in all sectors in implementing Smart Industry solutions, from the up- and reskilling of entire teams to the delivery of complete projects.
Our added value? Make the incredible happen!
At Akkodis, you can take your career into the direction you want: choose a consulting role, become part of a solutions teams or be at the forefront of new innovations from within our own research centers… the choice is yours!
JOB DESCRIPTION :
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.
Tasks and responsibilities in each field
• 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 sub-teams and provide statistical support and solutions
• Provide input to internal process improvements and/or new statistical programming capabilities
• Maintain current scientific and regulatory knowledge
Competencies required for support level:
• Bsc. in Statistics, Mathematics, Informatics or equivalent
• Experience as a statistical programmer in the pharmaceutical industry
• Proficient in English (oral and written)
• Excellent programming skills in SAS (Macro, SQL) and R (function, package)
• Able to develop, validate and maintain programs
• Excellent understanding of the standardization and automatization processes
• Excellent knowledge of statistical concepts and statistics applied to non-clinical, pre-clinical and clinical data
• Excellent knowledge of GCP and ICH guidelines
• Excellent 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
• Excellent knowledge of CDISC standards (ADaM, SDTM)
If you have not received a response within 48 hours of applying, please assume you have not been shortlisted this time.