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 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 are responsible for ensuring the timely availability 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 results from clinical studies and development plans, working 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 support accurate and prompt decision-making. Serve as a statistical representative within cross-functional study teams and project sub-teams, providing 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 relevant to the role. Support Level 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 to build relationships with internal and external stakeholders and explain complex statistical concepts understandably. Leadership skills to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team player with experience 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