Biostatistician

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 delivering high-quality analysis results in a timely manner to support decision-making. You will also oversee and guide teams and outsourcing partners in statistical matters. Key Tasks and Responsibilities: Provide statistical input for the design, analysis, and interpretation of clinical studies and development plans, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams. Write and review essential clinical and statistical documents including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR). Ensure the delivery of high-quality, timely statistical analysis results to facilitate accurate and prompt decision-making. Serve as a statistical representative within cross-functional study teams and project sub-teams, offering statistical support and solutions. Provide statistical support for briefing books, submissions, health authority requests, publications, and other relevant documents. Support interactions with health authorities. Contribute to internal process improvements and the development of new statistical capabilities. Maintain up-to-date scientific and regulatory knowledge in the field. 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, capable of building good relationships with internal and external stakeholders and explaining complex statistical concepts understandably. Leadership qualities, with the ability to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team player, capable of 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

Location: trentino-alto-adige, IT

Posted Date: 6/15/2025