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 be responsible for delivering high-quality analysis results in a timely manner to support decision-making. You will also oversee and guide statistical aspects within teams and with outsourcing partners. Responsibilities: Provide statistical input for the design, analysis, and interpretation of clinical studies, collaborating 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, timely statistical analysis results to support decision-making processes. Represent statistics within cross-functional study teams and project sub-teams, providing support and solutions. Support the preparation of briefing books, submissions, health authority requests, publications, and other relevant documentation. Engage with health authorities during interactions. Contribute to internal process improvements and the development of 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 (spoken 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 understanding of GCP and ICH guidelines. Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good relationships with stakeholders. Leadership qualities to lead statistical and programming teams. Ability to manage, drive, and meet project timelines. Team player with experience working in multidisciplinary teams. Deep knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical familiarity with CDISC standards (ADaM, SDTM). Extensive experience in submissions and interactions with health authorities. J-18808-Ljbffr

Location: ferrara, IT

Posted Date: 5/10/2025