JR Italy

Biostatistician

Job Location

provincia-di-cagliari, 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 steer your career in the direction you desire: choose a consulting role, join solutions teams, or be at the forefront of new innovations from within our research centres… the choice is yours! Job Description: As a biostatistician, you will: Provide expert statistical input for development plans, study design, protocol writing, analysis, and interpretation of clinical study results. Ensure timely delivery of high-quality analysis results to support decision-making. Offer statistical oversight and guidance to teams and outsourcing partners. Key responsibilities include: Design, analyze, and interpret clinical study data in collaboration with stakeholders. Draft and review essential documents such as protocols, SAP, DMP, CRF, and CSR. Deliver high-quality statistical analyses promptly to facilitate decision-making. Represent statistics within cross-functional teams, providing support and solutions. Assist with regulatory submissions, health authority interactions, and relevant publications. Contribute to process improvements and develop new statistical capabilities. Maintain current knowledge of scientific and regulatory standards. 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). Programming skills in SAS (Macro, SQL) and R. Strong knowledge of statistical methodologies applied to clinical projects. Ability to propose and implement new statistical methods. Excellent understanding of GCP and ICH guidelines. Strong communication skills to explain complex statistical concepts to non-statisticians. Leadership qualities to manage statistical and programming teams. Ability to manage timelines and work effectively in multidisciplinary teams. Knowledge of regulatory requirements such as ICH E9/E10 and CDISC standards (ADaM, SDTM). Experience with submissions and interactions with health authorities. J-18808-Ljbffr

Location: provincia-di-cagliari, IT

Posted Date: 5/9/2025
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JR Italy

Posted

May 9, 2025
UID: 5187715007

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