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 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 are responsible for delivering high-quality analysis results in a timely manner to support decision-making. You will also 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, 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), Prescription Drug Monitoring Programs (PDMP), Case Report Forms (CRF), and Clinical Study Reports (CSR). Deliver high-quality, timely statistical analysis results to support correct and prompt decision-making. Serve as a statistical representative within cross-functional study teams and project sub-teams, providing statistical support and solutions. Support interactions with health authorities through relevant documentation and communication. Contribute to internal process improvements and development of new statistical capabilities. Maintain current scientific and regulatory knowledge in the field. Required Competencies: Master's 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, capable of building good relationships with internal and external stakeholders and explaining complex statistical concepts understandably. Leadership skills, with the ability to lead statistical and programming teams. Ability to manage, drive, and meet project timelines. Team player, capable of working in multidisciplinary teams. Comprehensive 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

Location: provincia-di-macerata, IT

Posted Date: 6/6/2025