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 in 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, study design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You are responsible for ensuring the timely delivery of high-quality analysis results to support decision-making. You will also provide statistical oversight and guidance to teams and outsourcing partners. Tasks and Responsibilities: Provide statistical input to the design, analysis, and interpretation of clinical studies, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams. Write and review key clinical and statistical documents, including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR). Deliver high-quality and timely statistical analysis results to facilitate correct and prompt decision-making. Serve as a statistical representative within cross-functional study teams and project sub-teams, offering statistical support and solutions. Support interactions with health authorities through documentation and communication. Contribute to internal process improvements and the development of new statistical capabilities. Maintain current scientific and regulatory knowledge in the field of biostatistics. Required Competencies: Master's or PhD in Statistics or a related field. Experience as a statistician in the pharmaceutical industry. Proficiency in English (oral and written). Strong programming skills in SAS (Macro, SQL) and R (functions, packages). Robust knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects. Ability to propose and implement new statistical methodologies. Excellent knowledge of GCP and ICH guidelines. Excellent communication skills, capable of building good relationships with stakeholders and explaining complex statistical concepts understandably. Leadership qualities to lead statistical and programming teams. Ability to manage, drive, and meet project timelines. Team player with experience working in multidisciplinary teams. Deep understanding of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical knowledge of CDISC standards (ADaM, SDTM). Extensive experience in submission processes and interactions with health authorities. J-18808-Ljbffr

Location: provincia-di-ravenna, IT

Posted Date: 6/16/2025