JR Italy
Biostatistician
Job Location
provincia-di-vercelli, Italy
Job Description
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, 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, contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You will be responsible for delivering high-quality analysis results on time to support decision-making. You will oversee and guide statistical aspects for teams and outsourcing partners. Tasks and Responsibilities: Provide statistical input for the design, analysis, and interpretation of clinical study results, collaborating with stakeholders such as clinical representatives, safety teams, and data management teams. Write and review key documents like Protocols, SAPs, DMPs, CRFs, and CSR. Deliver high-quality, timely statistical analysis results to facilitate accurate decision-making. Serve as a statistical representative in cross-functional study teams, offering support and solutions. Support the preparation of briefing books, submissions, and responses to health authorities. Engage with health authorities as needed. Contribute to process improvements and enhance 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). Deep understanding of statistical methodologies applied to clinical and pre-clinical projects. Ability to propose and implement new statistical methods. Excellent knowledge of GCP and ICH guidelines. Strong communication skills, capable of explaining complex statistical concepts understandably. Leadership qualities to lead statistical and programming teams. Ability to manage and meet project timelines. Team-oriented, capable of working in multidisciplinary teams. Extensive knowledge of regulatory requirements like ICH E9/E10. Technical familiarity with CDISC standards (ADaM, SDTM). Significant experience in submissions and interactions with health authorities. J-18808-Ljbffr
Location: provincia-di-vercelli, IT
Posted Date: 5/9/2025
Location: provincia-di-vercelli, IT
Posted Date: 5/9/2025
Contact Information
Contact | Human Resources JR Italy |
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