Statistical Programmer Lazio

Statistical Programmer
Roma
Lazio, Lazio

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 documentDevelop Define. Xml and Analysis Data Reviewer's Guide (ADRG) for data submissionProgram and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R function/package following good programming practicesAct as a statistical programming representative within cross-functional study teams and project sub-teams and provide statistical support and solutionsProvide input to internal process improvements and/or new statistical programming capabilitiesMaintain current scientific and regulatory knowledgeCompetencies required for support level:Bsc.

in Statistics, Mathematics, Informatics or equivalentExperience as a statistical programmer in the pharmaceutical industryProficient in English (oral and written)Excellent programming skills in R (function, package) and SAS (Macro, SQL)Able to develop, validate and maintain programsExcellent understanding of the standardization and automatization processesExcellent knowledge of statistical concepts and statistics applied to non-clinical, pre-clinical and clinical dataExcellent knowledge of GCP and ICH guidelinesExcellent communication skills, able to build good relationships with internal and external stakeholdersTeam player, able to work in a multidisciplinary teamAble to manage, drive and meet delivery timelinesExcellent knowledge of CDISC standards (ADaM, SDTM)