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 up- and reskilling entire teams to delivering complete projects. Our added value? Make the incredible happen! At Akkodis, you can shape your career: choose a consulting role, become part of solutions teams, or be at the forefront of new innovations within our 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 clinical study results. You will ensure timely availability of high-quality analysis results to support decision-making and 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 and development plans, collaborating closely with stakeholders (e.g., clinical representatives, safety team, data management team). Write and review key clinical and statistical documents (e.g., Protocol, SAP, DMP, PDMP, CRF, CSR). Deliver high-quality and timely statistical analysis results to support decision-making. Act as a statistical representative within cross-functional study teams and project sub-teams, providing support and solutions. Support interactions with health authorities and contribute to submissions, briefing books, publications, and other relevant documents. Contribute to internal process improvements and new statistical capabilities. Maintain current scientific and regulatory knowledge. Required Competencies: MSc or PhD in Statistics or a related field. Experience as a statistician in the pharmaceutical industry. Proficiency in English (oral and written). Good programming skills in SAS (Macro, SQL) and R (functions, packages). Strong 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, with the ability to explain complex statistical concepts to non-statisticians. Leadership skills to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team player, capable of working 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 interactions with health authorities. J-18808-Ljbffr

Location: provincia-di-latina, IT

Posted Date: 5/10/2025