Clinical Statistical Programmer
Job Description
<p>Akkodis, a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.</p><p><br></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 & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines β Consulting, Solutions, Talents and Academy β 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><br></p><p>As part of our growth in the region and our portfolio development, we are looking for a Clinical Statistical programmer</p><p><br></p><p><span>Brief description of the job</span></p><p><span>As a Clinical Statistical Programmer, you provide statistical programming expertise to deliver high-quality</span></p><p><span>programs and outputs for analysis of clinical data. It is your responsibility to provide high-quality analysis results</span></p><p><span>on time to support efficient decision making.</span></p><p><span> </span></p><p><span>Description of tasks and responsibilities in each field</span></p><p><span>ο </span><span>Develop Analysis Data Model (ADaM) datasets</span></p><p><span>ο </span><span>Develop Tables, Figures and Listings / Output and Programming Specification (TFL/OPS) from the</span></p><p><span>Statistical Analysis Plan (SAP) or a related document</span></p><p><span>ο </span><span>Develop Define.xml and Analysis Data Reviewerβs Guide (ADRG) for data submission</span></p><p><span>ο </span><span>Program and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R</span></p><p><span>function/package following good programming practices</span></p><p><span>ο </span><span>Act as a statistical programming representative within cross-functional study teams and project subteams</span></p><p><span>and provide statistical support and solutions</span></p><p><span>ο </span><span>Provide input to internal process improvements and/or new statistical programming capabilities</span></p><p><span>ο </span><span>Maintain current scientific and regulatory knowledge</span></p><p><span> </span></p><p><span>Competencies required for support level (Senior)</span></p><p><span>ο </span><span>Bsc. in Statistics, Mathematics, Informatics or equivalent</span></p><p><span>ο </span><span>At least 5 years of experience as a statistical programmer in the pharmaceutical industry</span></p><p><span>ο </span><span>Proficient in English (oral and written)</span></p><p><span>ο </span><span>Advanced programming skills in SAS (Macro, SQL) and R (function, package)</span></p><p><span>ο </span><span>Able to develop, validate and maintain programs</span></p><p><span>ο </span><span>Good understanding of the standardization and automatization processes</span></p><p><span>ο </span><span>Good knowledge of statistical concept and statistics applied to non-clinical, pre-clinical and clinical</span></p><p><span>data</span></p><p><span>ο </span><span>Good knowledge of GCP and ICH guidelines</span></p><p><span>ο </span><span>Good communication skills, able to build good relationships with internal and external stakeholders</span></p><p><span>ο </span><span>Team player, able to work in a multidisciplinary team</span></p><p><span>ο </span><span>Able to manage, drive and meet delivery timelines</span></p><p><span>ο </span><span>Advanced knowledge of CDISC standards (ADaM, SDTM)</span></p><p><span>ο </span><span>Good ADaM and metadata writing skills</span></p><p><br></p><p><span>Job Location : Dubai – JLT</span></p><p><br></p>
