Requirements: English
Company: Akkodis
Region: Chieti , Abruzzo
Biostatistician Our mission at Akkodis is clear:create a smarter future together! We are a one-stop-shop forengineering, IT, Life Science, and new technologies. Our combinedpassion for talent and technology allows us to look at the worlddifferently. With our 360 offer we support companies in allsectors in implementing Smart Industry solutions, from the up- andreskilling of entire teams to the delivery of complete projects.Our added value? Make the incredible happen! At Akkodis, you cantake your career into the direction you want: choose a consultingrole, become part of a solutions teams or be at the forefront ofnew innovations from within our own research centres the choice isyours! JOB DESCRIPTION : As a biostatistician, you provide expertstatistical input and contribute to development plans, design,protocol writing, statistical analysis, and interpretation ofresults from clinical studies. You are accountable for timelyavailability of high-quality analysis results to support decisionmaking. You provide statistical oversight and guidance to teams andoutsourcing partners. Tasks and responsibilities in each field: -Provide statistical input to the design, analysis, andinterpretation of results from clinical studies, and developmentplans in close interaction with different stakeholders (e.g.,clinical representatives, safety team, data management team) -Write and review key clinical and statistical documents (e.g.,Protocol, Statistical Analysis Plan [SAP], Data Management Plan[DMP], Prescription Drug Monitoring Program [PDMP], Case ReportForm [CRF], Clinical Study Report [CSR]) - Provide high-quality andtimely statistical analyses results to support correct and timelydecision making. - Act as a statistical representative withincross-functional study teams and project sub-teams and providestatistical support and solutions. - Provide statistical supportfor briefing books, submissions, health authorities requests,publications, and other relevant documents. - Support interactionswith health authorities - Provide input to internal processimprovements and/or new statistic capabilities. - Maintain currentscientific and regulatory knowledge. Competencies required forsupport level: - Msc. or PhD in Statistics or related field -Experience as a statistician in the pharmaceutical industry -Proficient in English (oral and written) - Good programming skillsin SAS (Macro, SQL) and R (function, package) - Strong statisticalmethodology knowledge applied to non-clinical/pre-clinical/clinicalprojects. - Able to propose and implement new statisticalmethodologies. - Excellent knowledge of GCP and ICH guidelines -Excellent communication skills, able to build good relationshipswith internal and external stakeholders, able to explain advancedstatistical concepts in terms understandable to non-statisticians.- Leadership, able to lead a statistical and a programming team. -Able to manage, drive and meet delivery timelines. - Team player,able to work in multidisciplinary teams. - Excellent knowledge ofregulatory requirements related to statistics (e.g., ICH E9/E10) -Technical knowledge of CDISC standards (ADaM, SDTM) - Strongexperience in submission and interaction with healthauthorities