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 steer your career in the direction you want: 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 be responsible for delivering high-quality analysis results in a timely manner to support decision-making. Additionally, you will oversee statistical aspects and guide teams and outsourcing partners. Tasks and Responsibilities: Provide statistical input for the design, analysis, and interpretation of clinical studies and development plans, collaborating with stakeholders (e.g., clinical representatives, safety team, data management team). Write and review key clinical and statistical documents (e.g., Protocol, SAP, DMP, CRF, CSR). Deliver high-quality, timely statistical analysis results to facilitate correct decision-making. Represent statistics within cross-functional study teams and project sub-teams, offering support and solutions. Support preparation of briefing books, submissions, health authority requests, publications, and other documents. Engage with health authorities as needed. Contribute to internal process improvements and development of new statistical capabilities. Maintain current scientific and regulatory knowledge. 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). Strong programming skills in SAS (Macro, SQL) and R. Solid knowledge of statistical methodologies applied to various project types. Ability to propose and implement new statistical methods. Excellent understanding of GCP and ICH guidelines. Effective communication skills to explain complex statistical concepts clearly. Leadership skills to guide statistical and programming teams. Ability to manage and meet project timelines. Team-oriented, capable of working in multidisciplinary teams. Knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical knowledge of CDISC standards (ADaM, SDTM). Extensive experience with submissions and interactions with health authorities. J-18808-Ljbffr