Biostatistician

Social network you want to login/join with: Our mission at Akkodis is clear: 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 solutions teams, or be at the forefront of new innovations from within our own research centres the choice is yours! JOB DESCRIPTION : As a biostatistician, you will provide expert statistical input and contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You will be accountable for the timely availability of high-quality analysis results to support decision-making. You will provide statistical oversight and guidance to teams and outsourcing partners. Tasks and responsibilities include: Provide statistical input to the design, analysis, and interpretation of results from clinical studies, and development plans in close interaction with 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 Report Form [CRF], Clinical Study Report [CSR]). Provide high-quality and timely statistical analysis results to support correct and timely decision-making. Act as a statistical representative within cross-functional study teams and project sub-teams, providing statistical support and solutions. Support interactions with health authorities and contribute to submissions, publications, and other relevant documents. Provide input to internal process improvements and develop new statistical capabilities. Maintain current scientific and regulatory knowledge. Competencies required: MSc. or PhD in Statistics or a related field. Experience as a statistician in the pharmaceutical industry. Proficient in English (oral and written). Good programming skills in SAS (Macro, SQL) and R (functions, packages). Strong statistical methodology knowledge applied to various projects. Ability to propose and implement new statistical methodologies. Excellent knowledge of GCP and ICH guidelines. Excellent communication skills, able to build relationships with stakeholders and explain complex statistical concepts clearly. Leadership skills, capable of leading statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team player, able to work in multidisciplinary teams. Excellent knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical knowledge of CDISC standards (ADaM, SDTM). Extensive experience in submission processes and interaction with health authorities. J-18808-Ljbffr

Location: bolzano, IT

Posted Date: 5/10/2025