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 steer your career in the direction you desire: choose a consulting role, join solutions teams, or be at the forefront of innovation 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, timely analysis results to support decision-making and will oversee statistical activities, guiding teams and outsourcing partners. Tasks and Responsibilities: Provide statistical input for the design, analysis, and interpretation of clinical studies in collaboration 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, timely statistical analysis results to support decision-making. Represent statistics within cross-functional study teams and provide support and solutions. Support the preparation of briefing books, submissions, health authority requests, publications, and other documents. Engage with health authorities as needed. Contribute to internal process improvements and develop new statistical capabilities. Maintain current scientific and regulatory knowledge. Support Level Competencies: MSc or PhD in Statistics or 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). Solid 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. Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good stakeholder relationships. Leadership qualities to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team player, capable of working in multidisciplinary teams. Excellent understanding of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical knowledge of CDISC standards (ADaM, SDTM). Extensive experience in submissions and interactions with health authorities. J-18808-Ljbffr

Location: la-spezia, IT

Posted Date: 6/16/2025