Biostatistician 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? Making 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 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 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 Provide statistical input for the design, analysis, and interpretation of clinical study results and development plans in collaboration 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], Clinical Study Report [CSR], Case Report Form [CRF]). 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 documents. Maintain current scientific and regulatory knowledge. Contribute to internal process improvements and develop new statistical capabilities. Competencies and Requirements 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 statistical methodology knowledge applicable to 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 clearly. Leadership skills to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team-oriented, capable of working in multidisciplinary teams. Knowledge of regulatory requirements (e.g., ICH E9 / E10) and CDISC standards (ADaM, SDTM). Experience in submission processes and interactions with health authorities. Location Macerata, The Marches, Italy J-18808-Ljbffr