Clinical Statistical Programmer

Job Description

<p>Akkodis, a global leader in the engineering and R&amp;D market that is leveraging the power of connected data to accelerate innovation and digital transformation.</p><p> </p><p>With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software &amp; technology services, robotics, testing, simulations, data security, AI &amp; data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market, and shape a smarter and more sustainable tomorrow. www.akkodis.com</p><p> </p><p>As part of our growth in the region and our portfolio development, we are looking for a Clinical Statistical programmer</p><p> </p><p><strong>Brief description of the job</strong></p><ul><li>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.</li></ul><p><br></p><p><strong>Description of tasks and responsibilities in each field</strong></p><ul><li>Develop Analysis Data Model (ADaM) datasets</li><li>Develop Tables, Figures and Listings / Output and Programming Specification (TFL/OPS) from the Statistical Analysis Plan (SAP) or a related document</li><li>Develop Define.xml and Analysis Data Reviewer’s Guide (ADRG) for data submission</li><li>Program and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R function/package following good programming practices</li><li>Act as a statistical programming representative within cross-functional study teams and project subteams and provide statistical support and solutions</li></ul><p> </p><p><strong>Competencies required for support level (Senior)</strong></p><ul><li>Bsc. in Statistics, Mathematics, Informatics or equivalent</li><li>At least 5 years of experience as a statistical programmer in the pharmaceutical industry</li><li>Proficient in English (oral and written)</li><li>Advanced programming skills in SAS (Macro, SQL) and R (function, package)</li><li>Able to develop, validate and maintain programs</li><li>Good understanding of the standardization and automatization processes</li><li>Good knowledge of statistical concept and statistics applied to non-clinical, pre-clinical and clinical data</li><li>Good knowledge of GCP and ICH guidelines</li><li>Good communication skills, able to build good relationships with internal and external stakeholders</li><li>Team player, able to work in a multidisciplinary team</li><li>Able to manage, drive and meet delivery timelines</li><li>Advanced knowledge of CDISC standards (ADaM, SDTM)</li><li>Good ADaM and metadata writing skills</li></ul>